Biologics CMC Regulatory Lead — Hybrid, Global Strategy

Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead global CMC regulatory strategy for monoclonal antibodies and other large molecules. This senior role partners with Process Development, Analytical Sciences, and Quality to optimize submissions and lifecycle management.

You will oversee FDA/EMA interactions, prepare CTD submissions, manage post‑approval changes, and mentor the CMC team in a fast-paced biotech environment.