Regulatory Affairs Lead, Oncology (Associate Director) (Northbrook)

About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. Purpose and Scope: This position plays a key role in the regulatory affairs department. Responsible for developing regulatory strategy for new assignments outside of existing regulatory frameworks (e.g., NDA strategy/planning for NMEs), with management oversight; driving submission related activities and successfully executing regulatory strategies. Responsibilities and Accountabilities: Actively seeks out knowledge of overall corporate strategy and other general factors that affect the regulatory positions taken within the company, and with the FDA and global health authorities, and incorporates this knowledge in interactions with others. Will also impact corporate strategy directly by participating in global strategic planning within therapeutic area project teams. Provides regulatory expertise for New Product Planning and Licensing due diligence activities. Member of important project teams/task forces requiring the interpretation of applicable FDA/ICH regulations to ensure compliance. Sets direction for key operations and new initiatives. Works closely with other individuals/groups within Regulatory Affairs to influence others to ensure departmental consistency and identifies options for risk discussions. Oversees submissions and compiles complex, strategic submissions for assigned projects. Ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Is considered a regulatory expert by global project teams/task forces and is accountable for developing and recommending regulatory strategy. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidances. Manages the preparation and review of registration packages to ensure effective data presentation and quality scientific data against regulatory requirements. Independently manages complex technical documents for preparation, review and submission to regulatory agencies. Interacts with FDA and global health authorities on project related communications, including facilitating Divisional and committee meetings such as Pre-IND, IND, Pre-NDA, and NDA meetings. Interacts with other companies such as contract manufacturers, external development partners, and other subsidiaries. Assists with ongoing training of Regulatory Affairs staff. Recognized as a person to whom others within the organization can consult to obtain answers to complex questions regarding FDA regulations and guidelines. Required Qualifications: Bachelor's degree in scientific discipline; advanced degree preferred. 9 years previous pharmaceutical drug development experience Recognized as an expert in regulatory aspects of pharmaceutical drug development involving undefined frameworks with technical complexity and broad scope. Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development. Recognized as an expert in an aspect of pharmaceutical drug development. Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to direct reports and others in the department as needed. Ability to communicate effectively and maintain effective working relationships. Must be able to positively influence department staff and cross-functional teams. Preferred Qualifications: Oncology experience strongly preferred 6 years regulatory affairs experience preferably involving direct contact with the FDA. Full knowledge of FDA and ICH regulations and guidelines, and the ability to provide interpretations of that information to others. Proven record of successful IND/NDA submissions and negotiations with the FDA. Global submission experience strongly desired Location and Working Environment This position is based in Northbrook, IL. Remote work from anywhere in the US is available. At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. What awaits you at Astellas? Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. Our Organizational Values and Behaviors Values: Innovation, Integrity and Impact sit at the heart of what we do. Behaviors: We come together as 'One Astellas', working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution. Salary Range $144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) Benefits: Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down 401(k) match and annual company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions Long Term Incentive Plan for eligible positions Company fleet vehicle for eligible positions Referral bonus program J-18808-Ljbffr

Senior Associate General Counsel (Corporate/Public Company) - Oahu (Honolulu)

Computer literate, including MS Suite. We recognize our competitive advantage our people. We believe in our people, who share our vision of meeting the needs of our employees, customers, and communities and who carry out the continued success of the company. Our employees are committed to the company's foundational values: integrity, excellence, teamwork, environmental stewardship, and community commitment. In turn, we invest in our employees, providing opportunities for challenge and advancement and offering a competitive compensation package. Posting End Date: This position will remain open until filled. Brief Posting Description The P Z8 EVP GENERAL COUNSEL Department of the P EVP GENERAL COUNSEL Division at Hawaiian Electric Company has 1 Management vacancy available. (Role: Manager) Job Function Provide in-house legal services for the benefit of Hawaiian Electric Industries, Inc., a publicly traded company listed on the NYSE, and its electric utility subsidiaries, Hawaiian Electric Company, Inc. (“Hawaiian Electric”), Maui Electric Company, Ltd. (“Maui Electric”) and Hawaii Electric Light Company, Inc.(“Hawaii Electric Light”) (collectively, the “Company”) with a focus on securities law, regulatory compliance, corporate governance, administration of executive compensation and retirement plans, capital markets, securities offerings, corporate and commercial transactions, and other legal issues affecting a NYSE publicly traded company and its subsidiaries. Essential Functions Securities Related Regulatory Compliance Ensures Company-wide securities law compliance, including compliance with SEC rules and regulations and NYSE listing standards including compliance with Regulations FD and G, administration of the Company’s insider trading policy and managing the Company’s relationship with the SEC and NYSE. Manages securities issuances, including registered offerings, stock-based compensation and matters relating to the DRIP. Oversees and assists in the drafting and legal review of all regulatory filings and disclosure documents (e.g., SEC 10-K/Q, 8-K, Proxy Statement) and Section 16 filings (e.g., Form 3, 4 and 5). Corporate Governance, Finance and Business Transactions Manages full life cycle of debt and equity financings, including drafting and negotiating agreements and supporting instruments, registration statements, board resolutions, etc. Provides legal advice and services with respect to a wide range of areas affecting the Company, including Hawaii corporate law, general business law, regulatory matters, general corporate governance, securities, finance, executive compensation and benefits and contracts. Provides such other services as requested by supervisor and consistent with the attorney’s abilities, education, and experience, including assistance with the department’s corporate secretary function. Assists with any M&A or other corporate transactions. Oversight Of Compensation And Incentive Plans Assists with compensation and ERISA-based plans, including defined benefit plans, defined contribution plans, equity incentive plans, deferred compensation plans and other stock-based plans. Legal Training/Programs Develops and implements legal training and other educational programs for Company management and employees with respect to rules and regulations, legal trends, relevant cases and policies and procedures related to the federal securities laws, NYSE rules and stock-related matters. Outside legal services Directs and manages work performed by outside attorneys, ensuring that cost effective, high caliber legal services are provided to the Company. Incident Management Team And Other Duties As assigned, participates as member of Hawaiian Electric, Maui Electric and/or Hawaii Electric Light’s Incident Management Teams (or similar team), and provides support to the same as needed, including any activities required to prepare for incident and emergency response. Performs other duties as assigned. Participates in Company emergency response activities as assigned, including any activities required to prepare for such emergency response. Knowledge Requirements Law degree, membership in the Hawaii State Bar Association and license to practice law in Hawaii (license to practice law and in good standing in another state will suffice pending admission to Hawaii bar within one year). Thorough knowledge in securities regulation, corporate and business law. General knowledge in other areas of the law such as executive compensation, contracts, litigation, employee benefits, regulatory, administrative, energy and real property. Working knowledge of accounting principles and financial statements is preferred. Skills Requirements Ability to work independently, manage time effectively, meet deadlines and deliver high quality work product with minimal oversight by supervisor. Ability to make mature, experienced business and legal judgments and apply strategic thinking. Ability to communicate clearly, persuasively, logically and succinctly (both verbally and in writing) for a variety of audiences in appropriate language (business and/or technical). Demonstrates a commitment to the Company’s core values (Safety, Aloha, Integrity and Excellence). Demonstrates a strong customer (internal and external) orientation and the ability to generate strong internal client satisfaction. In depth analytical, organizational and conceptual skills to handle various projects and programs. Ability to identify, analyze and research legal issues affecting the Company, and make recommendations to address the issues. Ability to identify legal options and provide creative solutions. Demonstrated ability to be flexible in a demanding work environment, handle multiple matters concurrently, remain calm/focused in stressful situations, and adapt to rapidly changing priorities. Ability to be a team player, work collaboratively, and delegate work and responsibilities as appropriate. Ability to mentor and train others. Computer literate, including MS Suite. Experience Requirements Minimum of 7 years of relevant legal experience. Minimum 3 years of advising public companies on corporate and securities matters (in-house or law firm). Role Manager Number of Vacancies: 1 Location Honolulu – Oahu Hiring Range The hiring range for the SR ASSOCIATE GENERAL COUNSEL (CORP) [Req ID 10654] position is $159,400.00 to $211,400.00. The person selected will be placed according to his/her skills and qualifications. About Hawaiian Electric Companies Hawaiian Electric Companies provide electricity and services to 95 percent of the state's 1.4 million residents. The company is also one of the state's leading employers and a major contributor and supporter of community and educational programs. The demand for power that has fueled the growth of the Hawaiian Islands has been met by Hawaiian Electric Companies for well over a century. And as the next millennium unfolds, the company is committed to providing quality service and seeking clean local energy sources to power generations of Hawaii families and businesses to come. Visit us at http://hawaiianelectric.com . Applicant Certification Authorize the Hawaiian Electric Companies to confirm all statements contained in the application and/or any materials submitted and made a part of the application as they relate to the position and to the extent permitted by law; Authorize and consent to, without reservation, the Hawaiian Electric Companies sharing any and all information regarding previous or present employment, educational training or personal information from their records and from any other source with the hiring department or subsidiary company; Release, discharge, and hold harmless, Hawaiian Electric Companies, from any and all liability for any damage which may be claimed as a result of furnishing such information to the hiring department or subsidiary company; Authorizes release and transfer of all personnel records to be maintained by the hiring company in the event of an inter-company transfer; and Authorize, direct, and consent to Hawaiian Electric Companies and/or its authorized agents to conduct investigations into candidates' background. These investigations may include, but are not limited to searches for information about applicants; record of criminal convictions to the extent permitted by law, education records, professional certifications, personal character references, and employment history. EEO Statement Hawaiian Electric Companies is an equal opportunity employer, including disability and protected veteran status. Affiliate Disclaimer The relationship between Hawaiian Electric and unregulated, energy-related affiliate companies is governed by the Affiliate Transaction Requirements (ATRs) established by the Hawaii Public Utilities Commission (PUC). The ATRs were established with the PUC’s Decision and Order No. 35962 issued on December 19, 2018, and subsequently modified by Order No. 36112, issued on January 24, 2019, in Docket No. 2018-0065. With Decision and Order No. 42409, issued on March 23, 2026, in Docket No. 2025-0391, the PUC indefinitely suspended certain sections of the ATRs. The ATRs address many issues related to Hawaiian Electric's interactions and transactions with Affiliate

General Manager (Raleigh)

Get to know us: NOVO Health Services offers linen management solutions to the healthcare industry. NOVO Health keenly focuses on safety and infection control and provides its partner hospitals with a value-driven linen management control system that measures and monitors linen utilization by department to eliminate excess internal costs. NOVO's wide range of service programs offer a variety of options to provide a seamless, single source distribution system. NOVO's regional healthcare linen facilities are HLAC accredited and operate with state-of-the-art processing equipment and processes. NOVO Health Services is a leading provider of healthcare linen solutions, delivering a fresh and innovative approach to the industry. Our focus on patient experience, infection prevention, and operational excellence enables us to improve linen quality while reducing overall program costs for our healthcare partners. With HLAC-accredited facilities and a commitment to continuous improvement, NOVO is redefining how healthcare linen programs are managed across the country. Position Summary The General Manager is a key leadership role responsible for the overall performance of a NOVO facility. Reporting to the VP of Operations, this position drives operational excellence across production, safety, quality, maintenance, logistics, and financial performance. This is a high-impact role requiring strong leadership, business acumen, and the ability to deliver results in a fast-paced, production-driven environment. The General Manager will lead teams, optimise operations, and ensure compliance with all regulatory and accreditation standards while supporting NOVO's continued growth. Key Responsibilities Lead all aspects of facility operations, including production, quality, safety, maintenance, logistics, and supply chain Develop and execute strategic plans aligned with company objectives to drive revenue growth and cost optimization Manage full P&L responsibility, including budgeting, forecasting, and financial performance Monitor and analyse KPIs to drive data-informed decisions and improve operational outcomes Optimise production processes, capacity planning, and inventory management to maximise efficiency and throughput Build, lead, and develop high-performing teams, fostering a culture of accountability, engagement, and continuous improvement Oversee talent acquisition, training, and performance management initiatives Ensure compliance with all applicable regulations, including HIPAA, OSHA, and DOT/FMCSA requirements Lead audit readiness, risk management, and accreditation efforts (HLAC and related standards) Identify and resolve operational challenges through root cause analysis and continuous improvement methodologies Partner with customers and stakeholders to ensure service excellence and strong client relationships Qualifications Bachelor's degree in Industrial Engineering, Business Administration, Mechanical Engineering, or related field 5 years of experience in a General Manager or senior operations leadership role within a production or manufacturing environment Proven success in driving operational performance, financial results, and team leadership Strong understanding of regulatory compliance (HIPAA, OSHA, DOT/FMCSA) Experience in industrial laundry, manufacturing, or similar high-volume production environments preferred Excellent leadership, communication, and problem-solving skills Proficiency in Microsoft Excel and other business systems What we can offer you as a full-time associate Competitive pay Paid Holidays Paid Time Off Program (PTO) 401(k) w/Employer Match Flexible Spending Account (FSA) Health Savings Account (HSA) Medical, Dental, and Vision Programs Basic Life/AD&D Insurance Long-Term Disability (LTD) Why work for Novo Health Services? NOVO Health Services strives to be the employer of choice in the hospital sterile and hygienically clean linen industry. To do that, we provide a safe, positive work environment where our associates experience tremendous growth and related opportunities for advancement. All applicants will be considered for employment without attention to race, color, sex, sexual orientation, gender identity, national origin veteran, or disability status. We are proud to be the equal opportunity workplace and an affirmative action employer. Drug-Free Workplace. J-18808-Ljbffr

General Counsel (Peachtree Corners)

Minard Enterprises is a private family office with a diverse portfolio spanning gaming, entertainment, technology, media, energy, and national security. Operating across 11 entities — including Legends Gaming (Georgia COAM), Intrepid Worldwide, RAOK Entertainment, and MIVP LLC — we move fast, think big, and operate at the intersection of commerce and community. The Role We're looking for a sharp, strategic General Counsel who can handle the full legal footprint of a multi-entity private office. You'll be the first dedicated in-house legal hire, partnering directly with the founder and executive leadership to protect the business, structure deals, and navigate regulatory complexity across multiple industries. What You’ll Own Full corporate legal function across all Minard entities Contract drafting, review, and negotiation (commercial, vendor, partnership, employment) Regulatory compliance across gaming (Georgia COAM), entertainment, technology, and emerging sectors Gaming licensing and compliance oversight — Georgia M&A and investment transaction support Risk management, litigation oversight, and outside counsel management Employment law guidance and HR legal support Entity governance, board matters, and subsidiary structuring What We’re Looking For JD from an accredited law school; active bar membership (Georgia preferred) 8 years of legal experience; in-house experience strongly preferred Gaming, entertainment, or heavily regulated industry background a significant plus Comfort operating as a solo practitioner within a lean organization — you're building this function Strong business judgment; you advise, not just review Discretion and integrity are non-negotiable Why This Role Direct access to founder and executive leadership Broad scope — no two days look the same Ground floor opportunity to shape the legal function of a growing private office Competitive compensation commensurate with experience J-18808-Ljbffr

Associate Director, Technology Sourcing (King of Prussia)

The Opportunity The Associate Director, Technology Sourcing is responsible for developing and executing strategic sourcing strategies for indirect goods and services within a defined portfolio of CSL enterprise-wide spend. The I&T sourcing lead will be accountable for securing maximum value from $450M in external spend, creating competitive advantage for CSL through year-over-year, multi-million-dollar savings, risk mitigation, supplier relationship management, innovation, and robust contractual negotiations. This role serves as the Global Subject Matter Expert (SME) for technology categories including hardware, software, data centers, IT maintenance, licenses, and other related services. The Associate Director will develop and execute senior-level stakeholder engagement and alignment strategies to ensure the current and future needs of the business are effectively addressed. You will provide guidance and leadership to Sourcing Managers within the team and be directly involved in major global sourcing initiatives, key transformational projects, and strategic supplier engagements. The role will build and maintain strong relationships with senior stakeholders across CSL and with large, global technology vendors, bringing leading-edge solutions and best practices into CSL to drive ongoing efficiency and value. Reporting directly to: Category Director - Enabling Functions Direct Reports: None Responsibilities Develop and execute global technology category strategies and multi-year roadmaps across software, SaaS, cloud services, infrastructure, hardware, telecommunications, cybersecurity, data centers, IT maintenance, and professional services. Establish annual action plans aligned with CSL’s business objectives, technology roadmap, operating models, and Procurement strategy. Lead complex, high-value strategic sourcing initiatives and competitive tendering processes, including RFPs, RFIs, and RFQs, driving negotiations and contract awards that optimize total cost of ownership, quality, service, innovation, risk, and long-term business value. Analyze spend, market trends, supplier dynamics, and supply risks to identify cost savings, demand management, supplier consolidation, license optimization, benchmarking, and other value creation opportunities while ensuring sourcing decisions support financial and operational objectives. Serve as the Global SME and strategic procurement advisor for technology categories, providing market intelligence, sourcing expertise, and strategic direction on complex initiatives while staying current on emerging technologies, commercial models, supplier innovations, and industry best practices. Build and maintain strong relationships with senior stakeholders and strategic suppliers, partnering across I&T, Information Security, Finance, Legal, and the broader business to translate business and technology requirements into effective sourcing, contracting, and supplier strategies. Provide strategic guidance to Sourcing Managers and collaborate with Procurement colleagues to ensure consistent execution of category strategies, sourcing initiatives, supplier management activities, and global procurement priorities. Lead strategic supplier relationship and performance management, including supplier governance, business reviews, KPIs, scorecards, SLAs, and continuous improvement programs. Establish appropriate governance for business-critical categories and drive year-over-year improvements in performance, service, quality, innovation, and value. Lead complex commercial and contractual negotiations with major global technology suppliers, including software licensing, cloud consumption models, SOWs, MSAs, and enterprise agreements, ensuring contracts appropriately address CSL’s commercial, operational, security, compliance, and business continuity requirements. Identify, assess, and mitigate supplier and category risks, including cybersecurity, data privacy, financial stability, supply continuity, regulatory compliance, and other operational risks. Develop long-term supplier continuity and risk mitigation strategies to protect CSL’s business. Drive procurement transformation and continuous improvement by leading complex problem resolution, data analytics, process reengineering, sourcing automation, and the implementation of sustainable global programs and best practices that improve efficiency and decision-making across CSL. Drive stakeholder alignment and executive engagement by serving as a strategic procurement partner and primary point of contact for assigned technology categories, building trusted relationships with senior CSL leaders and executives at strategic global suppliers to address business priorities, supplier performance, procurement initiatives, and broader organizational opportunities. Monitor and report category and supplier performance using financial and operational KPIs, dashboards, and data-driven insights. Provide recommendations and updates to Procurement leadership and key stakeholders across I&T, Finance, and other business functions to support informed decision-making. Champion strong procurement governance and ethical sourcing practices, ensuring sourcing and supplier activities adhere to CSL policies, applicable laws and regulations, anti-bribery requirements, conflict-of-interest standards, and other governance requirements, while supporting supplier diversity and inclusion objectives. Additional Responsibilities: Risk management. Training and development. Market intelligence sharing. Support change initiatives. Stakeholder engagement. Qualifications Bachelor’s degree in Procurement, Supply Chain Management, Business, Information Technology, Computer Science, Engineering, or a related discipline. 7 years of progressive experience in procurement, strategic sourcing, category management, or a related discipline, with significant experience managing technology and IT categories within a complex, global or multi-site organization. Demonstrated experience developing and executing global category strategies across technology spend, including enterprise software, SaaS, cloud services, IT infrastructure, hardware, telecommunications, cybersecurity, data centers, IT maintenance, and technology professional services. Proven success leading complex, high-value sourcing initiatives and negotiations, including enterprise software licensing, SaaS agreements, cloud commercial models, managed services, strategic technology partnerships, and other enterprise technology contracts. Strong understanding of technology commercial and contractual structures, including Master Service Agreements (MSAs), SaaS agreements, software licensing, cloud terms, maintenance agreements, Statements of Work (SOWs), and other enterprise technology agreements. Demonstrated experience in strategic supplier relationship management, including supplier selection and evaluation, governance, performance management, business reviews, KPIs, risk mitigation, continuity planning, and continuous improvement. Strong financial and analytical acumen, with experience in spend analysis, market and supplier analysis, benchmarking, TCO, cost modeling, and identifying measurable savings and value creation opportunities. Exceptional stakeholder management and influencing skills, with the ability to build trusted relationships and influence senior I&T, business, Finance, Legal, Information Security, and other functional leaders in a global environment. Strong negotiation, communication, project management, and problem-solving skills, with the ability to lead complex cross-functional initiatives and translate data and insights into actionable sourcing strategies and business decisions. Experience working across global organizations and time zones, with the ability to effectively manage relationships with senior internal stakeholders and external executives at strategic global suppliers. Experience with procurement and sourcing technologies such as SAP Ariba, Coupa, Jaggaer, Ivalua, or similar platforms, as well as Contract Lifecycle Management (CLM), spend analytics, and related procurement tools preferred. Professional procurement certification such as ISM/CPSM, CPM, or CIPS preferred. Demonstrated ability to identify and implement innovative sourcing strategies and best practices that improve efficiency, mitigate risk, support technology transformation, and deliver sustainable year-over-year value for CSL. Travel Approximately 5% domestic and international travel expected. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/. Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with