Senior Manager, Regulatory Affairs

Sanofi Genzyme

Tokyo, Japan
Japan regulatory strategy formulation
Pmda consultation meetings leadership
J-ctd module preparation

Skills & Requirements

Must-have

  • Japan regulatory strategy formulation
  • PMDA consultation meetings leadership
  • J-CTD module preparation
  • Japanese Package Insert revisions
  • Cross-functional stakeholder coordination

Nice-to-have

  • Native-level Japanese language proficiency
  • Strong negotiation and communication skills
  • Problem-solving mindset
  • Collaborative team culture contribution

Key Requirements

  • Bachelor's degree or higher in scientific field
  • Minimum 2 years experience in R&D or regulatory affairs
  • Business-level English (TOEIC 800+)
  • Native-level Japanese required

Work Rights

Not specified

Tailored Resume

Cover Letter