Senior Director, CMC Regulatory - Small Molecules

Beeline Medicines in Massachusetts is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead all CMC activities from IND/CTA through NDA and post‑approval lifecycle. You will partner with Technical Development, Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure compliant submissions and robust CMC strategies.

You will shape regulatory strategy, manage Health Authority interactions (FDA/EMA), oversee submissions in ICH CTD format, mentor teams, and