Position Japan Regulatory Strategy Manager

Amgen Inc

Tokyo, Japan
Not specified
10+ years regulatory affairs experience
5+ years japan regulatory experience
Native level japanese language skills
Amgen Inc. is seeking a Japan Regulatory Strategy Manager in Tokyo, aiming to enhance regulatory strategies for clinical trials and marketing licenses. The ideal candidate will have extensive experience in regulatory affairs, particularly in Japan, and will play a key role in aligning local strategies with global regulatory objectives

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 will serve as the primary interface with Japanese health authorities including PMDA and MHLW to facilitate drug approvals.
  • Amgen offers vast opportunities for professional growth within a diverse and inclusive community committed to patient care.

Matching Summary

Match Score: 85

Amgen Inc. is seeking a Japan Regulatory Strategy Manager in Tokyo, aiming to enhance regulatory strategies for clinical trials and marketing licenses. The ideal candidate will have extensive experience in regulatory affairs, particularly in Japan, and will play a key role in aligning local strategies with global regulatory objectives.

Skills & Requirements

Must-have

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

Nice-to-have

  • Advanced degree in relevant field
  • TOEIC score of 860 or higher
  • Experience with Orphan Drug Applications
  • Ability to influence global strategy
  • Strong cross-functional collaboration skills

Key Requirements

  • Bachelor's degree required
  • 10+ years directly related experience
  • 5+ years in Regulatory Affairs
  • In-depth knowledge of Japan legislation
  • English communication proficiency

Work Rights

Not specified

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