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 regulatory submissions.
  • Lead and mentor junior staff, enhancing team capabilities and supporting health authority interactions.

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 and mentoring staff

Nice-to-have

  • negotiating with health authorities
  • influencing health authorities
  • working across functions
  • identifying and mitigating risks

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter