Senior Manager - Associate Director, Regulatory Affairs, Japan

BeiGene

Japan, Japan
Japan regulatory strategies
Drug development lifecycle management
Health authority interactions in japan
The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives

Job Summary

  • The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives.
  • Responsibilities include providing high-level strategic and operational regulatory direction, preparing and submitting documentation to Japan Health Authorities, and liaising with regulatory agencies for all aspects pertaining to drug development.
  • BeiGene offers a market-competitive compensation package including performance-based bonuses and company shares, in-house and external learning opportunities, and a fantastic benefits program.

Matching Summary

The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives.

Skills & Requirements

Must-have

  • Japan regulatory strategies
  • drug development lifecycle management
  • Health Authority interactions in Japan
  • ICH regulatory requirements
  • CTN, NDA, BLA submissions

Nice-to-have

  • collaborative and supportive team
  • passionate interest in fighting cancer
  • bold ingenuity and driving excellence
  • entrepreneurial mindset

Key Requirements

  • Minimum 10 years in biotechnical or pharmaceutical industry
  • Minimum 5 years in Regulatory capacity
  • Minimum 5 years on Japan development programs
  • Experience with small molecules and biologics
  • Excellent Japanese and English communication skills

Work Rights

Not specified

Tailored Resume

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