Japan Regulatory Strategy Manager

Amgen UK

Tokyo, Japan
**
10+ years regulatory affairs experience
5+ years japan regulatory experience
Native level japanese language skills
** Amgen UK is seeking a Japan Regulatory Strategy Manager to lead regulatory strategies and maintain compliance for clinical trials and marketing licenses in Japan. The ideal candidate will have extensive experience in regulatory affairs, strong English and Japanese communication skills, and the ability to work cross-functionally within a global team. **

Job Summary

  • Amgen is seeking a qualified candidate to develop and execute regulatory strategies for obtaining clinical trial and marketing licenses in Japan.
  • The role requires acting as the primary interface with Japanese health authorities like PMDA and MHLW to facilitate drug approvals.
  • Candidates will work closely with global teams to integrate Japan-specific regulatory strategies into the broader global development plan.

Matching Summary

Match Score: 75

** Amgen UK is seeking a Japan Regulatory Strategy Manager to lead regulatory strategies and maintain compliance for clinical trials and marketing licenses in Japan. The ideal candidate will have extensive experience in regulatory affairs, strong English and Japanese communication skills, and the ability to work cross-functionally within a global team. **

Skills & Requirements

Must-have

  • 10+ years Regulatory Affairs experience
  • 5+ years Japan regulatory experience
  • Native level Japanese language skills
  • High level English language skills
  • PMDA and MHLW interaction expertise
  • New Drug Application (NDA) filing experience

Nice-to-have

  • Advanced degree preferred
  • TOEIC score 860 or higher
  • Experience influencing global strategy
  • Strong interpersonal influence skills
  • Matrix environment collaboration

Key Requirements

  • Bachelor's degree required
  • 10+ years directly related experience
  • 5+ years in Regulatory Affairs
  • In-depth knowledge of Japan legislation
  • Scientific/Technical excellence

Work Rights

Not specified

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