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Global CMC Regulatory Lead - Late-Stage & Lifecycle

Job in San Jose, Santa Clara County, California, 95199, USA
Listing for: Otsuka Pharmaceutical Co., Ltd.
Full Time position
Listed on 2026-10-02
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Pharmaceutical Manufacturing, Pharma Engineer, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 150000 - 224000 USD Yearly USD 150000.00 224000.00 YEAR
Job Description & How to Apply Below

Otsuka Pharmaceutical Co., Ltd. seeks a senior CMC Regulatory Affairs professional to develop and execute global regulatory strategies for CMC regulatory aspects of late-stage and lifecycle management across regions.

You will lead submissions, respond to health authorities, and guide cross-functional teams to ensure timely approvals. Responsibilities include planning CMC sections, monitoring regulatory updates, and representing CMC RA in global project teams across EMA, FDA, and other

This Full Time position is for the Global CMC Regulatory Lead
- Late-Stage & Lifecycle role at Otsuka Pharmaceutical Co., Ltd.

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

Our team is growing, and we are hiring a Global CMC Regulatory Lead
- Late-Stage & Lifecycle in United States.

This Full Time opening is for the Global CMC Regulatory Lead
- Late-Stage & Lifecycle role at Otsuka Pharmaceutical Co., Ltd.

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