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. 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.