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Senior Director, Biologics CMC Regulatory Strategy

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Beeline Medicines
Full Time position
Listed on 2026-07-27
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
  • Management
    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 is seeking a Senior Director, Regulatory Affairs CMC – Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global regulatory standards.

As a senior leader, you will drive cross‑functional teams, influence regulatory decisions, and shape

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Position Requirements
10+ Years work experience
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