Head of Regulatory CMC Strategy, Biosimilars

Head of Regulatory CMC Strategy, Biosimilars

About the Company

AI-native biopharmaceutical company expanding access to biosimilar medicines across the Americas.

Industry
Biotechnology

Type
Privately Held, VC-backed

About the Role

The Company is seeking a Head of Regulatory CMC Strategy for Biosimilars, a pivotal role in the strategic expansion of its biosimilar medicine portfolio. The successful candidate will be responsible for owning and shaping the end-to-end regulatory CMC strategy for biosimilar programs, with a focus on the 351(k) pathway. This includes leading all FDA interactions, authoring and overseeing CMC sections of IND and BLA submissions, and developing analytical similarity strategies to support clinical efficacy waivers. The role demands a deep expertise in biosimilar regulatory pathways, a strong track record in IND/BLA authorship, and experience in program design and development execution aligned with FDA expectations. The ideal candidate will have a background in monoclonal antibodies or complex biologics, with a preference for those with startup or lean biotech experience. Key responsibilities also include managing CDMO relationships, evaluating data for submission readiness, and contributing to cross-functional leadership and company-building efforts. The Head of Regulatory CMC Strategy will work within an AI-native operating model, leveraging advanced tools and automation, and will be instrumental in the company's mission to bring monoclonal antibody programs to market more efficiently and cost-effectively. A builder mindset, strong strategic thinking, and the ability to operate in a high-ownership, fast-paced environment are essential for this role.

Travel Percent
Less than 10%

Functions

• Strategy
• Operations