Head of Regulatory CMC Strategy, Biosimilars

Head of Regulatory CMC Strategy, BiosimilarsAbout the CompanyAn AI-native biopharmaceutical company focused on expanding access to biosimilar medicines across the Americas.IndustryBiotechnologyTypePrivately Held, VC-backedAbout the RoleThe 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 managing CDMO relationships within an outsourced development model. The ideal candidate will have a background in monoclonal antibodies or complex biologics, with a preference for those with startup or lean biotech experience, and a builder mindset suited to high-ownership, fast-paced environments. Key responsibilities for the Head of Regulatory CMC Strategy include defining regulatory requirements, designing development blueprints, and guiding external partners to ensure the successful execution of the program strategy. The role also involves cross-functional leadership, partnering with regulatory affairs, and contributing to the overall company strategy and culture. The candidate should be a strategic thinker, capable of translating regulatory requirements into executable plans, and be prepared to work in a fully outsourced model with a focus on accelerating development and reducing costs. This is a unique opportunity to be part of a company that is at the forefront of the biosimilar market, with a strong emphasis on AI-native operating models and a commitment to expanding access to affordable medicines.Travel PercentLess than 10%FunctionsStrategyOperations