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Strategic Regulatory Affairs Lead – CMC (Biotech

Job in High Point, Guilford County, North Carolina, 27264, USA
Listing for: Doist
Full Time position
Listed on 2026-07-30
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below
Position: Strategic Regulatory Affairs Lead – CMC (Biotech)

United Therapeutics is seeking a Regulatory Affairs Manager (CMC) to lead regulatory submissions for US, EU, and ROW. The role drives CMC strategies and collaborates with manufacturing, quality, and partner teams to ensure compliant filings.

The position focuses on mentoring staff, guiding labeling, and ensuring timely delivery of dossiers across multiple territories, with a hybrid work schedule at the Durham, NC office.

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