Construction

Director, Global Regulatory Lead, GI & Inflammation (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Head of Global Product Labeling (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions. Precedent Search and Labeling Trends Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10 years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6 years regulatory and/or related experience. Strategic Thinking Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately

  • Boston, MA

  • no content

Director, Global Regulatory Lead, GI & Inflammation - Strategic Leadership in Global Regulatory Affairs (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 4 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

  • no content

Director, Global Regulatory Affairs, Neuroscience (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio . This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams . Defines , develops , and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations . Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Participates in cross- functiona l initiatives within Global Regulatory Affairs and Takeda R&D . How you will contribute: The Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs. Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 10 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Acceptable and independent skills in the area of regu

  • Cambridgeport, MA

  • no content

Senior Leader of Regulatory Operations CMC (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Acts as mentor / coach to other GRA CMC members. How you will contribute: Develops, executes and oversees the preparation of major global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters. Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Providing strategic input into change control evaluation - as required. As a GRA CMC member, ensures and / or enhances regulatory compliance. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Proactively identifies regulatory CMC risks, ensuring timely communication with line management. Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target. Supports development of strategies, tools, and trainings to further the GRA CMC roadmap. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required. 10 years of overall biopharmaceutical/device industry experience with 8 years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Applies direction taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and lon

  • Cambridgeport, MA

  • no content

Sr. Utilities Technician - Waste Water - Expertise in Advanced Plant Equipment Maintenance (SOCIAL CIRCLE)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Utilities Technician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies. How will you contribute: Perform preventive, corrective and predictive maintenance of all associated equipment. Operate and maintain various equipment through routine inspection and review. All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies. Read, understand, and follow related SOPs and job/work plans. Ensure that forms and work order documentation are completed with accurate information. Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises. Provide support for the start-up of new equipment to ensure it meets all mechanical design specifications. Develop a proficiency in three or more advanced maintenance technologies and understand how to apply technology to improve equipment reliability, e.g., alignment, balancing, thermography, oil analysis, ultrasound, or vibration monitoring. Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws. Collect and Analyze daily WWTP as per procedure Perform chemical / parameter adjustment in WWTP as need it to maintain the system in compliance Perform Disposal of Hazardous Waste Respond to urgent and emergency work orders for the utilities department as needed. Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP). Attend required Instructor Lead Training and planned team meetings Demonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving. Order and Maintain chemical inventory Keeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain) Ability to teach basic activities and work execution to other technicians. Maintain a positive, professional, and customer-oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to their supervisor, or management. This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician. Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments. May perform other duties as assigned. Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps. Operate general laboratory equipment to assess the analytical status of the utilities process. What you bring to Takeda: Typically requires a high school diploma or GED plus 8 years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred. Two-year certificate in a technical field such as HVAC, building trades or building utilities program, or equivalent military experience is preferred. 5-6 years of experience in the maintenance trades is preferred Ability to read and understand technical manuals and wiring schematics Must have good customer service skills and promote a teamwork environment Must have GA Industrial Wastewater Operator license or higher (or ability to get it within 90 days of employment) Ability to effectively communicate ideas through verbal and written form. Ability to read and understand procedures, schematics, and job blueprints. Familiar with CMMS, SAP, JDE, and or Maximo Must be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Excellent technical troubleshooting/problem solving skills are a must. Must be knowledgeable with respect to the operation and maintenance of various utility systems including DAF, Centrifuge, Aeration Basins, Blowers, Pumps and others. Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. May be exposed to sunlight and heat. May be exposed to dust, gases, and fumes. May be required to stand and walk frequently while evaluating utilities equipment. May be around moving equipment and machinery. May climb up and into large tanks for inspection. May work in a loud area that requires hearing protection and other protective equipment to be worn. May be required to work or be assigned to a different shift as needed. Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts. Overtime may be required at times. Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities. May be required to lift up to 50 pounds when managing chemicals. No travel is expected with this position. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. GMSGQ ZR1 LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - GA - Social Circle - Hwy 278 U.S. Hourly Wage Range: $27.55 - $43.26 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan an

  • Social Circle, GA

  • no content

Lead Utilities Maintenance Specialist (SOCIAL CIRCLE)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: The Utilities Technician is responsible for the operation, maintenance, and troubleshooting of plant equipment that supports utilities including but not limited to high-pressure steam boilers; chillers; heating/cooling air handling units; process wastewater treatment systems; water purification system (water softening and carbon bed filtration, reverse osmosis, continuous deionization equipment, sanitary pumps, multi-effect distillation equipment); tank mixers; air compressors and dryers; and chilled water distribution systems under minimum supervision of the utilities supervisor in rotation shift environment. Performs corrective maintenance and routine preventative maintenance on plant utilities equipment following Standard Operating Procedures (SOPs) as necessary. Completing work orders, logs and forms following cGMP documentation practices and Quality Standards in a Pharmaceutical Manufacturing facility is mandatory. This senior position is responsible for performing daily checks and maintenance on facility equipment and systems while adhering to cGMP standards and corporate safety policies. How will you contribute: Perform preventive, corrective and predictive maintenance of all associated equipment. Operate and maintain various equipment through routine inspection and review. All work must be completed in accordance with cGMPs, SOPs, job plans, and company policies. Read, understand, and follow related SOPs and job/work plans. Ensure that forms and work order documentation are completed with accurate information. Responds to calls and conduct repairs throughout the facility. May be assigned to escort a contractor performing work on the premises. Provide support for the start-up of new equipment to ensure it meets all mechanical design specifications. Develop a proficiency in three or more advanced maintenance technologies and understand how to apply technology to improve equipment reliability, e.g., alignment, balancing, thermography, oil analysis, ultrasound, or vibration monitoring. Must follow safety rules and ensure compliance with GA state and federal EPA regulations and laws. Collect and Analyze daily WWTP as per procedure Perform chemical / parameter adjustment in WWTP as need it to maintain the system in compliance Perform Disposal of Hazardous Waste Respond to urgent and emergency work orders for the utilities department as needed. Responsible for closing assigned work orders in the CMMS (JDE, Maximo, SAP). Attend required Instructor Lead Training and planned team meetings Demonstrate continuous progress with respect to increasing job knowledge and proficiency in technical understanding/problem-solving. Order and Maintain chemical inventory Keeps designated area 5S'd. (Safety, Sort, Shine, Standardize, Sustain) Ability to teach basic activities and work execution to other technicians. Maintain a positive, professional, and customer-oriented attitude. Communicate any concerns related to safe work practices, hostile work environment, sexual harassment or any other type of employee misconduct directly to their supervisor, or management. This position will receive general instruction on routine work with detailed instruction on new assignments. Often will be assigned to work with a less experienced, utilities or maintenance technician. Primarily interacts with Plant Engineering Department personnel. Moderate interaction with other departments. May perform other duties as assigned. Provide a limited level of troubleshooting, diagnostic, and repair of building systems, equipment, and equipment components. Manufacturing equipment vessels, mixers, valves, and pumps. Operate general laboratory equipment to assess the analytical status of the utilities process. What you bring to Takeda: Typically requires a high school diploma or GED plus 8 years of related industrial related experience. Pharmaceutical, utilities, and/or WWTP experience preferred. Two-year certificate in a technical field such as HVAC, building trades or building utilities program, or equivalent military experience is preferred. 5-6 years of experience in the maintenance trades is preferred Ability to read and understand technical manuals and wiring schematics Must have good customer service skills and promote a teamwork environment Must have GA Industrial Wastewater Operator license or higher (or ability to get it within 90 days of employment) Ability to effectively communicate ideas through verbal and written form. Ability to read and understand procedures, schematics, and job blueprints. Familiar with CMMS, SAP, JDE, and or Maximo Must be able to understand cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry. Excellent technical troubleshooting/problem solving skills are a must. Must be knowledgeable with respect to the operation and maintenance of various utility systems including DAF, Centrifuge, Aeration Basins, Blowers, Pumps and others. Familiarity with Microsoft Office Applications, SCADA, process control software, and other computer base applications Important Considerations: At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may: Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. May be exposed to sunlight and heat. May be exposed to dust, gases, and fumes. May be required to stand and walk frequently while evaluating utilities equipment. May be around moving equipment and machinery. May climb up and into large tanks for inspection. May work in a loud area that requires hearing protection and other protective equipment to be worn. May be required to work or be assigned to a different shift as needed. Must be able to work 12-hour shifts and rotate(2/2/3) with assigned shifts. Overtime may be required at times. Requires performing activities within the plant utilities equipment, mechanical work, and computer-based activities. May be required to lift up to 50 pounds when managing chemicals. No travel is expected with this position. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. GMSGQ ZR1 LI-MA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: USA - GA - Social Circle - Hwy 278 U.S. Hourly Wage Range: $27.55 - $43.26 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan an

  • Social Circle, GA

  • no content

Associate Director, Global Regulatory Affairs CMC (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: With minimal supervision, develops and leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products. RA CMC member on the Global Regulatory CMC team. May serve as or act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. Has a strong and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions. Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. How you will contribute: With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, may represent Takeda RA CMC in Health Authority meetings and support CMC preparation activities for meetings with Health Authorities on CMC related matters. Interacts directly with international Health Authorities on administrative procedural topics, as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Evaluates change proposals for global regulatory impact. As a GRA CMC member, ensures regulatory compliance with HA regulations. Assures conformance with Takeda controlled procedures and GRA CMC best practices. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Supports and/ or leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred. 10 years of overall biopharmaceutical/device industry experience with 5 years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered). Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines. Able to deal with issues of critical importance with minimal supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management. Understands who is responsible for different decisions and escalates as necessary. Applies decisions taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies the given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

  • Cambridgeport, MA

  • no content

Senior Manager of International Regulatory Affairs (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of multiple products in various stages of drug development, assigned to self or direct reports, including at least one high complexity product and updates to or creation of a new TLP, CCDS, USPI and EU SmPC. How you will contribute: Management of Labeling Cross-Functional Teams Leads Labeling cross-functional teams providing leadership to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) In alignment with TAU/MPD Labeling Lead, coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team (Global Labeling Oversight Committee - GLOC) providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels. Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions. Labeling Documents Authoring, Submission, and Labeling Negotiations Independently authors new/revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation. In a highly efficient manner, develops and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers while minimizing the risk of write-offs. Responsible for working with direct reports to develop and/or review the labeling implementation plan ensuring that the most up-to-date information and in compliance with labeling requirements is provided to patients and Health Care Providers while the risk of write- offs is minimized. Independently authors/manages of outgoing communications regarding significant labeling changes and CCDS changes for assigned products. Employs strong project management skills to coordinate global labeling sub-functions to ensure timely end to end label creation and timely Health Authority submission and key role in label negotiations with Health Authorities (leading or in conjunction with GRL). Assess and interpret laws, regulations, and guidance documents relevant to the development and implementation of labeling documentation and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions Manages process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals. Provides support to Local Affiliates for responses to health authorities requests, review of local labeling exceptions and alignment deferrals, etc. Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation. Spearhead the establishment and cultivation of powerful relationships among functions represented at the Labeling cross functional teams, including clinical, safety, medical affairs, and commercial, to ensure unparalleled communication effectiveness for labeling strategy and content. Thorough understanding of company specific matrix organization, functional impact and regional representation to proactively build the relationships needed to be successful across functions, departments and regions. Precedent Search and Labeling Trends Conducts precedent searches, analyzes relevant competitor labeling, health authority labeling requests for Takeda products, labeling guidance and trends; and develops strategies and labeling language for inclusion assigned product labels (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Takeda products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals. Analyzes relevant competitor labeling and recent product approvals, health authority labeling requests for Takeda products and labeling guidance and trends at portfolio level to drive the development of essential, innovative, industry-leading product labeling to patients and health care professionals. Working within Labeling Team and GRA Represents Global Labeling at Global Regulatory Team (GRT) Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Embraces pivotal role in departmental and cross-functional task-forces and initiatives. Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes. People Management Effectively manages resources and staff to ensure optimal performance and provides comprehensive guidance, supervision, and support to GLLs in carrying out their labeling responsibilities. Supports the professional development of staff members and effectively manages their performance. Demonstrate ownership to consistently drive the delivery of team goals fostering accountability while remaining focused on the big picture labeling strategy. Vendor Management Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards. Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy. Minimum Requirements/Qualifications: BSc degree, preferred; BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred. 10 years of pharmaceutical industry experience. This is inclusive of 8 years of labeling experience or combination of 6 years regulatory and/or related experience. Strategic Thinking Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management and in alignment with broader business objectives. Demonstrates a strong understanding of the core business aspect. Ability to effectively collaborate with global cross-functional reams and to deliver engaging and valuable presentations to diverse stakeholders. Ability to build a collaborative network of relationships across global cross-functional teams. Demonstrate strong communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation format. Ability to advocate for regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives, addressing their concerns and formulating appropriate questions to verify their complete understanding. Analytical and Problem Solving Skills Demonstrates deep understanding of analytical methodologies and problem-solving technique to handle complex problems. Ability to comprehend, explain, and efficiently communicate complex labeling related regulatory issues. Ability to assess complex labeling related regulatory requirements, proactively anticipate issues or opportunities and take actions before they arise, escalate to leadership, as needed, and making informed decisions aligned with portfolio priorities. Ability to proactively identify risks, develop creative solutions and risk mitigation strategies, and appropriately

  • Boston, MA

  • no content

Senior Director, Regulatory Affairs, Neurotherapeutics (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio . This is accomplished through leadership of product-specific Global Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams . Defines , develops , and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Keeps abreast of new developments in regulatory science and maintains oversight on the evolving regulatory landscape and advancing innovations . Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Participates in cross- functiona l initiatives within Global Regulatory Affairs and Takeda R&D . How you will contribute: The Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types such as original NDA/BLAs. Direct point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors Minimum Requirements/Qualifications: BSc Degree, preferred. BA accepted. 10 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 5 years regulatory and/or related experience. Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Acceptable and independent skills in the area of regu

  • Cambridgeport, MA

  • no content

Associate Director, Global Regulatory Affairs - GI & Inflammation (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Objective / Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as applicable. Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts. Accountabilities: The Associate Director will be responsible for complex or highly complex or multiple projects. Leads the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as the Label Working Group, and represents GRTs at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. Ensures global regulatory strategies defined within the GRT are effectively implemented and maintained in line with changing regulatory and business needs and anticipates such changes to lead adaptations to regulatory strategy. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions. Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible. The Director will lead all submission types. Accountable for building global regulatory strategies as defined within the GRT and ensure those are effectively implemented and maintained in line with changing regulatory and business needs. Direct point of contact with health authorities, leads and manages FDA meetings. Manages direct reports or junior staff as needed. Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products. Oversee vendor responsibility for regulatory activities and submissions related to projects within scope. Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Lead regulatory reviewer in due diligence for licensing opportunities. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. Responsible for demonstrating Takeda leadership behaviors. Education & Competencies: Bachelor’s Degree, scientific discipline strongly preferred Advanced degree in a scientific discipline (PharmD/PhD/MD) strongly preferred 6 years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory experience Preferred experience in reviewing, authoring, or managing components of regulatory submissions. Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. Understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy. Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Demonstrates strong skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Must work well with others and within global teams. Able to bring working teams together for common objectives. Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

  • Cambridgeport, MA

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Head of International Regulatory Strategy CMC (BOSTON)

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Acts as mentor / coach to other GRA CMC members. How you will contribute: Develops, executes and oversees the preparation of major global registrational submissions. Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters. Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required. Fosters constructive working relationships when interacting with internal and/or external colleagues. Providing strategic input into change control evaluation - as required. As a GRA CMC member, ensures and / or enhances regulatory compliance. Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities. Proactively identifies regulatory CMC risks, ensuring timely communication with line management. Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle. Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations. Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target. Supports development of strategies, tools, and trainings to further the GRA CMC roadmap. Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate. Minimum Requirements/Qualifications: BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required. 10 years of overall biopharmaceutical/device industry experience with 8 years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered. Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support. Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams. Analyze issues with attention to detail. Ability to assess alternative approaches. Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines Able to deal with issues of critical importance with minimal oversight. Exercises good judgment in elevating and communicating actual or potential issues to line management. Applies direction taken by the company. Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork. Intentionally promotes an inclusive culture. Applies given prioritization framework with limited support. Excellent written and oral communication skills required. Exercises good judgement in elevating and communicating actual or potential issues to line management. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy. LI-Hybrid LI-AA1 Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $177,000.00 - $278,080.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and lon

  • Cambridgeport, MA

  • no content