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Biologics CMC Regulatory Senior Director – Hybrid

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Beeline Medicines Corporation
Full Time position
Listed on 2026-07-29
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 242000 - 313500 USD Yearly USD 242000.00 313500.00 YEAR
Job Description & How to Apply Below

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

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Position Requirements
10+ Years work experience
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