Regulatory Cmc Expert (manager), Japan

Century Center

Tokyo, Japan
On-site
Cmc regulatory aspects
Japanese regulations and requirements
Japanese health authorities
The job posting is for a Regulatory CMC Expert (Manager) at CSL Behring in Tokyo, Japan. The role involves evaluating CMC regulatory aspects, developing CMC strategies, and preparing regulatory dossiers while collaborating with internal and external partners

Job Summary

  • The Regulatory CMC Expert evaluates all CMC regulatory aspects related to the assigned products in Japan, developing and executing CMC strategies for development and established products.
  • This role involves preparing CMC regulatory dossiers in accordance with Japanese regulations and requirements, and materials for negotiations with Japanese Health Authorities.
  • The position requires overseeing and interpreting regulatory requirements, acting as a Subject Matter Expert, and providing technical guidance to local CMC specialists.

Matching Summary

Match Score: 85

The job posting is for a Regulatory CMC Expert (Manager) at CSL Behring in Tokyo, Japan. The role involves evaluating CMC regulatory aspects, developing CMC strategies, and preparing regulatory dossiers while collaborating with internal and external partners.

Skills & Requirements

Must-have

  • CMC regulatory aspects
  • Japanese regulations and requirements
  • Japanese Health Authorities
  • Fluent Japanese and English communication

Nice-to-have

  • collaboration with team members
  • organizational values and operational excellence
  • external and strategic focus
  • high quality communication
  • effective negotiation skills

Key Requirements

  • At least 5 years pharmaceutical industry experience in CMC
  • At least 3 years Regulatory CMC experience
  • Bachelor’s degree in a Life Science
  • Japanese regulatory legislation expertise

Work Rights

Not specified

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