Position Japan Regulatory Strategy Manager

Amgen UK

Tokyo, Japan
10+ years regulatory affairs experience
5+ years japan regulatory experience
Native level japanese language skills
The role involves developing and executing regulatory strategies to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan

Job Summary

  • The role involves developing and executing regulatory strategies to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan.
  • Candidates must act as the primary interface with Japanese health authorities (MHLW and PMDA) to facilitate drug approvals and clinical development.
  • Amgen offers vast opportunities to learn and move up across its global organization within a diverse and inclusive community of belonging.

Matching Summary

The role involves developing and executing regulatory strategies to obtain and maintain clinical trial and marketing licenses for Amgen molecules in Japan.

Skills & Requirements

Must-have

  • 10+ years Regulatory Affairs experience
  • 5+ years Japan regulatory experience
  • Native level Japanese language skills
  • TOEIC score 860 or higher
  • PMDA and MHLW interaction expertise

Nice-to-have

  • Advanced degree preferred
  • Experience with Orphan Drug Applications
  • Ability to work in matrix environments
  • Strong influence and engagement skills
  • Process standardization leadership

Key Requirements

  • Bachelor's degree required
  • 10+ years directly related experience
  • 5+ years Japan regulatory experience
  • English proficiency TOEIC >= 860
  • Native Japanese language capability

Work Rights

Not specified

Tailored Resume

Cover Letter