Head Of Biologics, China Cmc Regulatory Affairs

Takeda

Shanghai, China
10+ years of relevant experience
Experience with cmc regulatory
Proven ability to liaise with regulatory agencies
Leads and oversees the development of regulatory CMC strategies for the Biologics CMC team

Job Summary

  • Leads and oversees the development of regulatory CMC strategies for the Biologics CMC team.
  • Independently plans and manages regulatory submissions for various phases of clinical development.
  • Builds and manages relationships with key internal and external stakeholders to drive regulatory support.

Matching Summary

Leads and oversees the development of regulatory CMC strategies for the Biologics CMC team.

Skills & Requirements

Must-have

  • 10+ years of relevant experience
  • Experience with CMC regulatory
  • Proven ability to liaise with Regulatory Agencies

Nice-to-have

  • Demonstrated leadership and problem-solving
  • Excellent written and oral communication skills
  • Ability to manage and mentor staff

Key Requirements

  • BS/BA Degree required
  • Minimum 3 years managing teams
  • Understanding of scientific principles and regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter