Manager, China Cmc Regulatory Affairs

Takeda

Beijing, China
Global regulatory strategies
Cmc requirements expertise
Health authority interactions
Develop and execute global regulatory strategies for assigned programs, collaborating with regional counterparts

Job Summary

  • Develop and execute global regulatory strategies for assigned programs, collaborating with regional counterparts.
  • Create and submit high-quality, compliant regulatory documents within defined timelines and manage submissions.
  • Lead and mentor junior staff, enhancing team capabilities and identifying/mitigating risks in regulatory strategies.

Matching Summary

Develop and execute global regulatory strategies for assigned programs, collaborating with regional counterparts.

Skills & Requirements

Must-have

  • global regulatory strategies
  • CMC requirements expertise
  • health authority interactions
  • regulatory submissions management
  • leading project teams

Nice-to-have

  • influencing health authorities
  • mentoring junior staff
  • risk mitigation in regulatory operations

Key Requirements

  • Expertise in regulatory strategies
  • Deep understanding of CMC requirements
  • Proven ability to negotiate with health authorities
  • Strong leadership skills
  • Skilled in managing regulatory submissions
  • Proficient in mentoring junior staff

Work Rights

Not specified

Tailored Resume

Cover Letter