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 to play a pivotal role in the strategic expansion of its biosimilar programs. This senior leadership position is focused on shaping and owning the end-to-end regulatory CMC strategy for biosimilar programs, particularly within the 351(k) pathway. The successful candidate will be responsible for leading all FDA interactions, including Type A/B meetings, and will have a key role in authoring and overseeing CMC sections of IND and BLA submissions. A deep expertise in biosimilar regulatory pathways, a strong track record of IND/BLA authorship, and experience in regulatory CMC, program leadership, or alliance management are essential. The role also involves defining regulatory requirements, developing analytical similarity strategies, and guiding external partners in the execution of program strategy. The ideal candidate will have a background in monoclonal antibodies or complex biologics, with a preference for those with startup or lean biotech experience. A builder mindset, strong strategic thinking, and the ability to translate regulatory requirements into executable plans are crucial. The Head of Regulatory CMC Strategy will also be involved in cross-functional leadership, partnering with regulatory affairs and executive leadership on overall strategy, and contributing to the company's culture and operating model. This is a unique opportunity to be part of a company that is at the forefront of advancing biosimilar medicines, with a focus on expanding access and operating with a hyper-lean, fully outsourced model.

Travel Percent
Less than 10%

Functions

• Strategy
• Operations