Head Of Regulatory Affairs

Biogen

Tokyo, Japan
Japan regulatory strategy
Bilingual english and japanese
Regulatory submissions preparation
This leadership role will be a key member of the Japan R&D Development team responsible for implementing and maintaining Japan regulatory processes and strategy

Job Summary

  • This leadership role will be a key member of the Japan R&D Development team responsible for implementing and maintaining Japan regulatory processes and strategy.
  • The role involves collaboration with global regulatory heads to ensure efficient global product development and regulatory solutions.
  • Biogen offers a pioneering spirit and a culture of inclusion and belonging, providing opportunities for learning, growth, and making a significant impact.

Matching Summary

This leadership role will be a key member of the Japan R&D Development team responsible for implementing and maintaining Japan regulatory processes and strategy.

Skills & Requirements

Must-have

  • Japan regulatory strategy
  • Bilingual English and Japanese
  • Regulatory submissions preparation
  • Leadership of regulatory staff
  • Interface with PMDA
  • Cross-functional collaboration

Nice-to-have

  • Strategic thinker
  • Global regulatory coordination
  • Mentorship and team development
  • Clinical development experience
  • Excellent communication skills

Key Requirements

  • Minimum 10 years strategic regulatory leadership
  • Minimum 5 years people management experience
  • Strong knowledge of Japan regulations
  • Experience with PMDA
  • BA/BS degree required, preferably PhD
  • Bilingual English and Japanese

Work Rights

Not specified

Tailored Resume

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