Head Of Biologics, China Cmc Regulatory Affairs

Takeda

Shanghai, China
Biologics cmc regulatory expertise
Nmpa submission dossier preparation
Health authority communication leadership
The role leads the development and implementation of regulatory CMC strategies for the Biologics team within China

Job Summary

  • The role leads the development and implementation of regulatory CMC strategies for the Biologics team within China.
  • Candidates must independently plan and execute regulatory submissions for various phases of clinical development and marketing applications.
  • The position requires managing staff and building constructive relationships with key internal and external stakeholders including NMPA and CDE.

Matching Summary

The role leads the development and implementation of regulatory CMC strategies for the Biologics team within China.

Skills & Requirements

Must-have

  • Biologics CMC regulatory expertise
  • NMPA submission dossier preparation
  • Health Authority communication leadership
  • Team management in matrix environment
  • ICH/WHO regulation interpretation

Nice-to-have

  • Strategic business development support
  • Due diligence participation experience
  • Cross-functional stakeholder relationship building
  • Proactive problem-solving capabilities
  • Innovative regulatory strategy development

Key Requirements

  • BS/BA degree required with 10+ years experience
  • Minimum 3 years managing teams
  • Experience with CMC regulatory for biologics
  • Proven ability to liaise with Regulatory Agencies

Work Rights

Not specified

Tailored Resume

Cover Letter