Position Japan Regulatory Strategy Manager

Amgen

Tokyo, Japan
On-site
Develop and execute regulatory strategies
Interface with regulatory authorities
Align with cross-functional partners
Amgen is seeking a Japan Regulatory Strategy Manager in Tokyo to lead regulatory strategy and submissions for drug development in alignment with local and global requirements. The ideal candidate should possess significant regulatory experience and strong interpersonal skills, particularly within the Japanese context

Job Summary

  • Develops and executes regulatory strategies and plans, providing strategic regulatory expertise for drug development and interfacing with regulatory authorities.
  • Leads the preparation of regulatory submissions, including NDAs, briefing documents, and CTNs, ensuring timely and compliant submissions.
  • Acts as the primary interface with MHLW and PMDA for product approval and clinical development, fostering good relationships with Japanese health authorities.

Matching Summary

Match Score: 85

Amgen is seeking a Japan Regulatory Strategy Manager in Tokyo to lead regulatory strategy and submissions for drug development in alignment with local and global requirements. The ideal candidate should possess significant regulatory experience and strong interpersonal skills, particularly within the Japanese context.

Skills & Requirements

Must-have

  • Develop and execute regulatory strategies
  • Interface with regulatory authorities
  • Align with cross-functional partners
  • Lead regulatory submissions
  • Ensure regulatory compliance

Nice-to-have

  • Proactively influence global strategy
  • Improve business processes
  • Demonstrate Amgen leadership behaviors

Key Requirements

  • Bachelor’s degree and 10+ years of experience
  • 5+ years of experience in Regulatory Affairs
  • Native level Japanese language skills
  • High level English language skills

Work Rights

Not specified

Tailored Resume

Cover Letter