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

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Job Description

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.

ACCOUNTABILITIES

• 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 antic