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 ...