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Regulatory Compliance Specialist

Global Regulatory Affairs Lead – CMC & Submissions

Job in 4800, Breda, North Brabant, Netherlands
Listing for: Biopharma Careers
Full Time position
Listed on 2026-09-03
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 90000 - 120000 EUR Yearly EUR 90000.00 120000.00 YEAR
Job Description & How to Apply Below
Amgen Breda is seeking a Regulatory Affairs Manager to translate CMC regulatory requirements into practical plans. You’ll support site-specific CMC sections for new applications and post-market updates, lead change control and submissions, and coordinate with global authorities.
The role requires a Doctorate/Master with 3+ years in pharma regulatory work or a Bachelor's with 5+ years in QA/RA. Strong English and Dutch skills are essential, with collaboration across multinational teams.

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