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Senior CMC Regulatory Manager - Hybrid, Global Submissions

Job in Gaithersburg, Montgomery County, Maryland, 20883, USA
Listing for: Green Key Resources
Full Time position
Listed on 2026-10-11
Job specializations:
  • Management
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 140000 - 190000 USD Yearly USD 140000.00 190000.00 YEAR
Job Description & How to Apply Below

Green Key Resources is seeking a highly technical Regulatory Affairs Manager / Senior Manager in Gaithersburg, MD for a 100% hands-on CMC role. The position is hybrid with onsite Tue-Thu.

You will author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a Master’s or PhD with extensive regulatory experience in commercial products and knowledge of FDA, Health Canada, and EMA requirements.

We have an opening for a Senior CMC Regulatory Manager
- Hybrid, Global Submissions in Gaithersburg, MD, United States within Legal, Management & Operations.

The Senior CMC Regulatory Manager
- Hybrid, Global Submissions position in the Legal, Management & Operations field is open for applications.

This role, Senior CMC Regulatory Manager
- Hybrid, Global Submissions at Green Key Resources, could be your next move.

Position Requirements
10+ Years work experience
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