Senior Manager Or Associate Director, Lifecycle Ra

BeiGene

Tokyo, JP
Market competitive compensation; performance-based...
Pmd act regulatory knowledge
Mhlw/pmda compliance expertise
Gmp inspection leadership
This role serves as the local representative for Regulatory Affairs and Compliance in Japan, focusing on post-marketing phases and proactive commercial regulatory requirements

Job Summary

  • This role serves as the local representative for Regulatory Affairs and Compliance in Japan, focusing on post-marketing phases and proactive commercial regulatory requirements.
  • The successful candidate will lead GMP inspections, manage business licenses, and coordinate CMC variation submissions with global teams.
  • BeOne offers a competitive compensation package including performance-based bonuses, equity plans, and opportunities to work with a dynamic global team fighting cancer.

Matching Summary

This role serves as the local representative for Regulatory Affairs and Compliance in Japan, focusing on post-marketing phases and proactive commercial regulatory requirements.

Salary

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

Skills & Requirements

Must-have

  • PMD Act regulatory knowledge
  • MHLW/PMDA compliance expertise
  • GMP inspection leadership
  • CMC variation submission management
  • Package insert maintenance

Nice-to-have

  • Strong cross-functional collaboration skills
  • Experience with global regulatory strategies
  • Ability to work in fast-paced environment
  • Proactive commercial regulatory input

Key Requirements

  • Bachelor or Master degree in Pharmacy or life science
  • Scientific background required
  • Proficiency in Microsoft Office suite

Work Rights

Not specified

Tailored Resume

Cover Letter