Regulatory Cmc Expert (manager), Japan

CSL Limited

Tokyo, Japan
**
Cmc regulatory aspects
Japanese ctd preparation
Japanese health authority interaction
** CSL Limited is seeking a Regulatory CMC Expert Manager for its Tokyo office, responsible for evaluating CMC regulatory aspects of both development and established pharmaceutical products in Japan. The ideal candidate will have extensive experience in CMC regulatory affairs, specifically within the Japanese pharmaceutical industry, and will play a key role in developing and executing CMC strategies while ensuring compliance with local regulations. **

Job Summary

  • The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products in Japan, developing and executing CMC strategies.
  • This role involves preparing CMC regulatory dossiers and materials for negotiations with Japanese Health Authorities.
  • The position requires overseeing and interpreting regulatory requirements, acting as a Subject Matter Expert, and developing effective working relationships with Japanese HAs.

Matching Summary

Match Score: 75

** CSL Limited is seeking a Regulatory CMC Expert Manager for its Tokyo office, responsible for evaluating CMC regulatory aspects of both development and established pharmaceutical products in Japan. The ideal candidate will have extensive experience in CMC regulatory affairs, specifically within the Japanese pharmaceutical industry, and will play a key role in developing and executing CMC strategies while ensuring compliance with local regulations. **

Skills & Requirements

Must-have

  • CMC regulatory aspects
  • Japanese CTD preparation
  • Japanese Health Authority interaction
  • Regulatory requirements interpretation
  • Life Science background

Nice-to-have

  • Collaboration with global teams
  • Negotiation skills
  • Technical guidance to specialists
  • CSL values alignment

Key Requirements

  • At least 5 years pharmaceutical industry experience in CMC
  • At least 3 years Regulatory CMC experience
  • Fluent Japanese and English communication skills
  • Bachelor’s degree in a Life Science

Work Rights

Not specified

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