Head Of Regulatory Affairs

Biogen

10 years strategic regulatory leadership experience
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 manage and mentor a team of regulatory staff while translating strategic business objectives into actionable plans.
  • Biogen offers a pioneering spirit 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 experience
  • 5 years people management experience
  • Bilingual English and Japanese proficiency
  • Experience with PMDA regulatory authority interactions
  • Preparation of major regulatory submissions

Nice-to-have

  • PhD in Life or Health Sciences preferred
  • Clinical development and planning experience
  • Strategic global thinking capabilities
  • Strong cross-functional collaboration skills

Key Requirements

  • Minimum 10 years strategic regulatory leadership
  • Minimum 5 years people management experience
  • Must be bilingual in English and Japanese
  • BA/BS degree required, PhD preferred
  • Life/Health Sciences background preferred

Work Rights

Not specified

Tailored Resume

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