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Senior Director, CMC Regulatory - Molecules

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: BioSpace
Full Time position
Listed on 2026-08-24
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 180000 - 260000 USD Yearly USD 180000.00 260000.00 YEAR
Job Description & How to Apply Below
Position: 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

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Position Requirements
10+ Years work experience
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