Director, Japan Cmc & Devices Regulatory Affairs, New Drug Application Group

Takeda UK

Osaka, Japan
Leadership in regulatory affairs
Cmc development strategies
Negotiation with health authorities
Lead the Japan CMC & Devices RA New Drug Application group to fulfill regulatory roles

Job Summary

  • Lead the Japan CMC & Devices RA New Drug Application group to fulfill regulatory roles.
  • Oversee regulatory CMC development and registration strategies for assigned products.
  • Contribute to delivering pharmaceuticals to patients in Japan.

Matching Summary

Lead the Japan CMC & Devices RA New Drug Application group to fulfill regulatory roles.

Skills & Requirements

Must-have

  • Leadership in Regulatory Affairs
  • CMC development strategies
  • Negotiation with Health Authorities

Nice-to-have

  • Strong stakeholder relationships
  • International perspective
  • Passion for new drug development

Key Requirements

  • 10+ years in pharmaceutical development
  • Experience with Japanese regulatory authorities
  • Business-level Japanese and English proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter