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Beeline Medicines

Senior Director, Biologics CMC Regulatory Strategy

boston, MA

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Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global regulatory standards.

As a senior leader, you will drive cross‑functional teams, influence regulatory decisions, and shape

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Worksite address

boston, MA, 02298, US

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