Biologics CMC Regulatory Senior Director – Hybrid

Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across Process Development, Analytical Sciences, and Quality to ensure regulatory compliance from IND/CTA through post‑approval lifecycle.

The role demands 12+ years of CMC regulatory experience, advanced education in a