Head Of Biologics, China Cmc Regulatory Affairs

Takeda

Shanghai, China
Biologics cmc regulatory strategy
China regulatory cmc
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.
  • Builds and manages constructive relationships with key internal and external stakeholders to drive Takeda positions and influence scientific approach and thought process to CMC topics.

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 regulatory CMC
  • Health Authority communication
  • NMPA submission dossier preparation
  • Cross-functional team leadership

Nice-to-have

  • Proactive issue communication
  • Business development evaluation
  • Staff professional development

Key Requirements

  • 10+ years relevant industry experience
  • Minimum 3 years managing teams
  • BS/BA Degree required
  • Experience with CMC regulatory for biologics

Work Rights

Not specified

Tailored Resume

Cover Letter