Biologics CMC Regulatory Strategy Lead (Hybrid)

Job description

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle.

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs, shaping global CMC submissions and health authority interactions (FDA/EMA). A proven leader with 12+ years in CMC regulatory affairs is required.

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Worksite address

boston, MA, 02298, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.