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Global CMC Regulatory Strategy Lead

Job in Annapolis, Anne Arundel County, Maryland, 21403, USA
Listing for: Otsuka America Pharmaceutical Inc.
Full Time position
Listed on 2026-07-30
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 150034 - 224250 USD Yearly USD 150034.00 224250.00 YEAR
Job Description & How to Apply Below

Otsuka America Pharmaceutical Inc. is seeking a CMC Regulatory Lead in Annapolis, Maryland. This role requires expertise in providing CMC regulatory strategies for biologics and small molecules, ensuring compliance with global regulatory requirements. Candidates should have significant experience in managing submissions and approvals for investigational products.

The successful candidate will engage with cross-functional teams and lead regulatory documentation efforts. Benefits include comprehensive medical coverage, 401(k) matching, and flexible time off.

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