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CMC Global Regulatory Lead; Late-Stage

Job in Philadelphia, Philadelphia County, Pennsylvania, 19117, USA
Listing for: Otsuka Pharmaceutical Co., Ltd
Full Time position
Listed on 2026-09-24
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Pharmaceutical Manufacturing, Pharma Engineer, Pharmaceutical Science/ Research
Salary/Wage Range or Industry Benchmark: 150000 - 224000 USD Yearly USD 150000.00 224000.00 YEAR
Job Description & How to Apply Below
Position: CMC Global Regulatory Lead (Late-Stage)

Otsuka Pharmaceutical Co., Ltd. is seeking a CMC Global Regulatory Affairs professional to develop and execute global regulatory strategies for CMC aspects of small molecule and biologic products.

The role covers late‑stage development and lifecycle management across regions with primary responsibility for EU/UK/CH and secondary US/Canada. The successful candidate will lead CMC submissions (IMPD/IND/MAA/NDA), anticipate regulatory changes, and oversee post‑approval variations.

Consider building your career as a CMC Global Regulatory Lead (Late-Stage) at Otsuka Pharmaceutical Co., Ltd.

We invite applications for the CMC Global Regulatory Lead (Late-Stage) position located in United States.

The following opening is for a CMC Global Regulatory Lead (Late-Stage) with Otsuka Pharmaceutical Co., Ltd.

Our organisation is growing, and we are hiring a CMC Global Regulatory Lead (Late-Stage) in United States.

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