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

Sanofi UK

Unknown, Unknown, United Kingdom
Not specified; not specified; not specified
Vaccine regulatory strategy establishment
Cta nda submission and approval experience
Dossier preparation and gap assessment
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 interactions with Health Authorities and coordinate cross-functional discussions to advance projects on schedule.
  • The position requires providing regulatory inputs for vaccine business in the China region while ensuring strict compliance with regulations.

Matching Summary

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

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Vaccine regulatory strategy establishment
  • CTA NDA submission and approval experience
  • Dossier preparation and gap assessment
  • Regulatory pathway and timeline management
  • Health authority interaction leadership
  • China region regulatory support

Nice-to-have

  • Cross-functional project team collaboration
  • Strategic risk mitigation capabilities
  • Ability to shape registration environment
  • Global and regional business alignment

Key Requirements

  • Senior Regulatory Affairs Manager experience
  • Expertise in CTA and NDA submissions
  • Knowledge of China regulatory landscape
  • Experience with vaccine product lifecycle

Work Rights

Not specified

Tailored Resume

Cover Letter