Ra Regcmc Manager

Sandoz

Head Office, Japan
Cmc regulatory strategy
Submission activities
High-quality ra cmc documentation
Responsible for CMC-related regulatory affairs activities to obtain regulatory approval for biosimilars in Japan

Job Summary

  • Responsible for CMC-related regulatory affairs activities to obtain regulatory approval for biosimilars in Japan.
  • Lead submission activities for assigned projects/products, ensuring compliance with regulatory requirements.
  • Initiate and lead Health Authority interactions and negotiations to support product success.

Matching Summary

Responsible for CMC-related regulatory affairs activities to obtain regulatory approval for biosimilars in Japan.

Skills & Requirements

Must-have

  • CMC regulatory strategy
  • submission activities
  • high-quality RA CMC documentation

Nice-to-have

  • cross-functional collaboration
  • effective working relationships
  • regulatory compliance

Key Requirements

  • operations management experience
  • preparation of RA CMC-related documents
  • experience with change management

Work Rights

Not specified

Tailored Resume

Cover Letter