Head Of Biologics, China Cmc Regulatory Affairs

Takeda UK

Shanghai, China
Biologics cmc regulatory strategy
China ra cmc expertise
Health authority communication
Leads and oversees the development and implementation of regulatory CMC development and registration strategies for the Biologics CMC team

Job Summary

  • Leads and oversees the development and implementation of regulatory CMC development and registration strategies for the Biologics CMC team.
  • Responsible for demonstrating Takeda leadership behaviors, lead for all CMC regulatory relevant activities for the Biologics CMC team.
  • Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.

Matching Summary

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

Skills & Requirements

Must-have

  • Biologics CMC regulatory strategy
  • China RA CMC expertise
  • Health Authority communication
  • NMPA submission dossier preparation
  • Global CMC plans alignment

Nice-to-have

  • Proactive communication with stakeholders
  • Business development due diligence
  • Influence scientific approach
  • Staff professional development

Key Requirements

  • 10+ years of relevant Industry, academic or HA experience
  • Advanced degree preferred
  • Minimum 3 years managing teams
  • BS/BA Degree required

Work Rights

Not specified

Tailored Resume

Cover Letter