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 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 ...