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Senior Director, Biologics CMC Regulatory Strategy

Job in Cambridge, Middlesex County, Massachusetts, 02140, USA
Listing for: Beeline Medicines
Full Time position
Listed on 2026-10-11
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
  • Management
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 242000 - 314000 USD Yearly USD 242000.00 314000.00 YEAR
Job Description & How to Apply Below

Beeline Medicines in Cambridge, MA seeks a Senior Director of Regulatory Affairs CMC – Biologics to lead global biologics CMC strategy from IND/CTA to BLA and post‑approval lifecycle.

You will partner with Process Development, Analytical Sciences, Quality, and external CMOs to oversee submissions, health authority interactions, and regulatory strategy, shaping infrastructure for antibodies and large molecules in a fast‑paced biotech setting.

As a Senior Director, Biologics CMC Regulatory Strategy, you will play an important part at Beeline Medicines in Cambridge, MA, United States.

We have an opening for a Senior Director, Biologics CMC Regulatory Strategy in Cambridge, MA, United States within Bio & Pharmacology & Health, Management & Operations.

This role, Senior Director, Biologics CMC Regulatory Strategy at Beeline Medicines, could be your next career step.

Are you ready to take on the Senior Director, Biologics CMC Regulatory Strategy role at Beeline Medicines?

Position Requirements
10+ Years work experience
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