Head of Regulatory CMC Strategy, Biosimilars

Head of Regulatory CMC Strategy, Biosimilars

About the Company

An AI-native biopharmaceutical company focused on 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 organization's strategic U.S. expansion. The successful candidate will be responsible for owning the end-to-end regulatory CMC strategy for biosimilar programs, leading FDA interactions, and authoring and overseeing CMC sections of IND and BLA submissions. This role demands a deep expertise in biosimilar regulatory pathways, particularly the 351(k) pathway, and a strong background in regulatory CMC, program leadership, or alliance management. The ideal candidate will have a proven track record in IND/BLA authorship, FDA interactions, and experience with CDMOs and outsourced development models. A background in monoclonal antibodies or complex biologics is preferred, with a strong emphasis on startup or lean biotech experience and a builder mindset. Key responsibilities for the Head of Regulatory CMC Strategy include defining regulatory requirements, developing analytical similarity strategies, and guiding external partners in executing program strategies. The role also involves managing CDMO relationships, evaluating data for quality and submission readiness, and operating effectively in a fully outsourced development model. The candidate should be a strategic thinker, capable of translating regulatory requirements into executable plans, and be prepared to contribute to the company's culture and operating model. This is a unique opportunity to shape regulatory strategy and development frameworks from the ground up, with direct access to executive leadership, within a company that is at the forefront of advancing biosimilar medicines.

Travel Percent
Less than 10%

Functions

• Strategy
• Operations