Global Head of BioLife Regulatory Affairs (Plasma, Devices and Transformation)

Takeda • Bannockburn, IL

2d • Hybrid

About The Position

About BioLife Plasma Services BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Limited, is an industry leader in the collection of high-quality plasma, which is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can’t be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 250+ state-of-the-art plasma donation centers across the United States. Our employees are dedicated to enhancing patients' quality of life and ensuring that the donation process is safe, straightforward, and rewarding for donors who wish to make a positive impact. When you work at BioLife, you’ll feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy. BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. OBJECTIVES/PURPOSE The Global Head of BioLife Regulatory is an enterprise regulatory leader responsible for defining and executing global regulatory strategy across BioLife plasma sourcing, collection, diversification, medical devices, donor interaction systems (DIS), and plasma center transformation initiatives. This role ensures that the regulatory strategy enables innovation, operational excellence, and long-term plasma supply resilience, while maintaining compliance with global health authority requirements. The VP serves as a strategic partner to BioLife, PDT (Plasma Derived Therapies), R&D, Quality, Operations, and Global Regulatory Affairs (CMC and Device), and represents the organization at senior levels with regulators and industry bodies. The Global Head of Global Regulatory Affairs for BioLife: Provides enterprise regulatory strategy and end-to-end regulatory leadership for plasma sourcing and collection activities, BioLife medical devices, and donor-facing digital and software-enabled systems, BioLife center transformation initiatives, and plasma diversification initiatives. Builds strong, trusted partnerships with key strategic partners within BioLife, PDT R&D, and the PDT BU, and leads regulatory collaboration across matrixed global teams and functions. Serve as an executive-level spokesperson with global health authorities, trade associations, and industry forums.

Requirements

• Extensive knowledge of regulatory requirements and demonstrated ability to function as the lead interface with Regulatory Authorities (e.g., cGMP, FDA, CLIA, OSHA, EU, State, PPTA).
• Demonstrated ability to develop and implement regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.
• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals.
• Ability to motivate, mentor, and manage a diverse team in a matrix environment.
• Global perspective with a demonstrated ability to work across functions, regions, and cultures.
• Ability to identify potential challenges and opportunities and make recommendations.
• Able to influence without authority at the senior leadership level.
• Accountable for acting decisively and exercising sound judgment in making decisions with limited information.
• Ability to challenge self and others to overcome regulatory barriers and deliver high-quality solutions to the business.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.
• Valuing and promoting differences by recognizing the importance of connections and bringing in key stakeholders to work towards the best possible solutions.
• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders.
• Disruptive thinker with the ability to influence and change how BioLife uses data to make decisions and set priorities.
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.
• Delivers solutions to abstract problems across functional areas of the business.
• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
• Resilient and comfortable working through large-scale global change management
• Bachelor’s degree required.
• 15+ years in health care with extensive senior‑level experience in global regulatory affairs within biologics, plasma, medical devices, and/or digital health
• Demonstrated experience engaging with FDA and global health authorities at senior levels.
• Proven ability to lead through transformation, complexity, and matrixed organizational structures.
• Strong executive presence with the ability to influence internally and externally.
• Strong technical background, including familiarity with US (FDA, CLIA, OSHA, State, PPTA) and International (e.g., EU) regulations related to plasma collection and/or manufacturing.
• Demonstrated ability to lead teams and collaborate with key cross-functional areas.
• Strong oral and written communication and negotiation skills
• Highest level of compliance, integrity, and business adaptability
• Domestic and international travel is required.

Nice To Haves

• Advanced degree in a scientific or health‑related discipline (e.g., PhD, PharmD, MD, MS) preferred

Responsibilities

• Enterprise regulatory strategy & leadership, including defining and executing enterprise‑wide regulatory strategy for BioLife plasma sourcing and collection that is aligned with PDT and Takeda objectives, providing senior‑level regulatory leadership to enable BioLife growth, modernization, and diversification initiatives, serving as a key advisor to executive leadership on regulatory risk, policy trends, and long‑range strategic planning, and ensuring regulatory considerations are embedded early in business, technology, and R&D decision‑making.
• Global regulatory strategy for plasma collections across all operations regions, acting as senior regulatory interface with FDA and global health authorities for plasma sourcing activities, and providing leadership for regulatory submissions, inspections, compliance, and lifecycle management of collection centers.
• End‑to-end regulatory leadership for BioLife medical devices and donor‑facing digital and software‑enabled systems, including regulatory pathways for design changes, system upgrades, automation, and new technology deployment, and partnering closely with Global RA CMC & Device, Quality, IT/Digital, and Operations to ensure compliant and scalable technology solutions.
• Regulatory leadership for BioLife transformation initiatives, including collection center modernization, automation, and new operating models, enabling innovation through proactive regulatory strategy that supports future‑state collection and donor engagement models, and anticipating evolving regulatory expectations related to digital health, data integrity, and integrated systems.
• Global strategic regulatory partner for plasma diversification initiatives, including supporting expansion across geographies, donor engagement approaches, and technology platforms, and shaping regulatory frameworks to support long‑term plasma supply resilience and sustainability.
• External and industry engagement, including serving as an executive‑level spokesperson with global health authorities, trade associations, and industry forums, influencing regulatory policy, standards, and guidance relevant to plasma collection, devices, and digital systems, and fostering constructive, transparent, and trust‑based relationships with regulators worldwide

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees