R&d - Gra - Senior Regulatory Affairs Manager - Bj

Sanofi

China
Establish regulatory strategy for new vaccines
Manage cta nda submission and approval processes
Lead interaction with health authorities in china
The role involves establishing and implementing regulatory strategies for new vaccines aligned with global and regional business goals

Job Summary

  • The role involves establishing and implementing regulatory strategies for new vaccines aligned with global and regional business goals.
  • Candidates will lead cooperative projects to shape the registration regulatory environment and interact effectively with Health Authorities.
  • Sanofi is committed to providing equal opportunities to all regardless of race, color, ancestry, religion, sex, or gender identity.

Matching Summary

The role involves establishing and implementing regulatory strategies for new vaccines aligned with global and regional business goals.

Skills & Requirements

Must-have

  • Establish regulatory strategy for new vaccines
  • Manage CTA NDA submission and approval processes
  • Lead interaction with Health Authorities in China
  • Conduct dossier preparation and gap assessments
  • Ensure regulatory compliance across project teams

Nice-to-have

  • Experience shaping registration regulatory environment
  • Cross-functional collaboration skills
  • Strategic input on RA regulations and trends
  • Ability to mitigate identified regulatory risks

Key Requirements

  • Senior level experience in Regulatory Affairs
  • Expertise in vaccine registration pathways
  • Knowledge of China region regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter