Senior Manager - Associate Director, Regulatory Affairs, Japan

BeOne

Market competitive compensation; performance-based...
Minimum 10 years pharmaceutical industry experience
5 years japan regulatory lead experience
Experience with small molecules and biologics
The role involves developing and advising on Japan regulatory strategies to secure market access for innovative cancer treatments

Job Summary

  • The role involves developing and advising on Japan regulatory strategies to secure market access for innovative cancer treatments.
  • Candidates must manage the full lifecycle of compounds through clinical development and post-approval phases while interfacing with Japan Health Authorities.
  • The company offers a competitive compensation package including performance-based bonuses, equity plans, and extensive learning opportunities.

Matching Summary

The role involves developing and advising on Japan regulatory strategies to secure market access for innovative cancer treatments.

Salary

Market competitive compensation; Performance-based annual bonus scheme; Generous welcome grant and performance-based annual equity plan

Skills & Requirements

Must-have

  • Minimum 10 years pharmaceutical industry experience
  • 5 years Japan regulatory lead experience
  • Experience with small molecules and biologics
  • Expertise in CTN, NDA, BLA, MAA submissions
  • Fluency in Japanese and English communication

Nice-to-have

  • Strong strategic thinking and creativity
  • Proven track record of significant accomplishments
  • Ability to build trust within organization
  • Collaborative and inclusive team spirit

Key Requirements

  • Minimum 10 years biotech/pharma experience
  • Minimum 5 years as Japan regulatory lead
  • Experience with both small molecules and biologics
  • Thorough understanding of Japan regulatory requirements
  • Excellent written and oral Japanese and English skills

Work Rights

Not specified

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