Head Of Regulatory Affairs

Biogen Support

10 years strategic regulatory leadership
5 years people management experience
Bilingual english and japanese proficiency
This leadership role serves as the primary contact for all Regulatory Authorities in Japan and defines strategies to mitigate product development risks

Job Summary

  • This leadership role serves as the primary contact for all Regulatory Authorities in Japan and defines strategies to mitigate product development risks.
  • The successful candidate will translate strategic business objectives into action while managing and mentoring a dedicated team of regulatory staff.
  • Biogen offers a stable environment where individual contributions make a significant impact on delivering life-changing medicines.

Matching Summary

This leadership role serves as the primary contact for all Regulatory Authorities in Japan and defines strategies to mitigate product development risks.

Skills & Requirements

Must-have

  • 10 years strategic regulatory leadership
  • 5 years people management experience
  • Bilingual English and Japanese proficiency
  • PMDA regulatory authority interaction
  • Major regulatory submission preparation

Nice-to-have

  • PhD in Life or Health Sciences
  • Global clinical development planning
  • Strategic thinking with global perspective
  • Cross-functional collaboration skills

Key Requirements

  • Minimum 10 years strategic regulatory leadership
  • Minimum 5 years people management experience
  • Strong knowledge of applicable Japan regulations
  • Experience interfacing with PMDA authorities
  • BA/BS degree required, PhD preferred

Work Rights

Not specified

Tailored Resume

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