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Global CMC Regulatory Manager – Rare Diseases; Hybrid

Job in Cary, Wake County, North Carolina, 27518, USA
Listing for: Chiesi
Full Time position
Listed on 2026-09-03
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 121000 - 182000 USD Yearly USD 121000.00 182000.00 YEAR
Job Description & How to Apply Below
Position: Global CMC Regulatory Manager – Rare Diseases (Hybrid)

Chiesi USA is seeking a Regulatory Affairs (RA) Manager with strong CMC pre- and post-approval experience to support Chiesi's Global Rare Diseases portfolio. The role is hybrid, based in Cary, NC, and requires leading CMC regulatory activities across submissions worldwide.

The candidate will author/review CMC sections, advise on regulatory expectations, coordinate with Core teams, and manage regulatory documents and timelines with minimal supervision.

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