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Senior Regulatory Affairs Leader - CMC Submissions (Remote

Remote / Online - Candidates ideally in
Deerfield, Lake County, Illinois, 60063, USA
Listing for: Amgen SA
Remote/Work from Home position
Listed on 2026-08-21
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 180000 - 190000 USD Yearly USD 180000.00 190000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Leader - CMC Submissions (Remote)

Amgen seeks a Regulatory Affairs Senior Manager to drive CMC regulatory strategies and coordinate cross-functional teams across regulatory submissions and health authority interactions. The role emphasizes developing risk registers, guiding CMC documentation, and ensuring compliance with evolving regulatory expectations.

You will collaborate with Technical Operations, R&D, and Commercial teams, ensuring timely, high-quality submissions and effective communication with health authorities.

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Position Requirements
10+ Years work experience
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