Senior Manager, Regulatory Affairs

IPSEN

Shanghai, China
License maintenance
Cta/nda submissions & approvals
Cde meetings preparation
Responsible for the regulatory activities in Ipsen China, including license maintenance, CDE meetings, CTA/NDA submissions & approvals

Job Summary

  • Responsible for the regulatory activities in Ipsen China, including license maintenance, CDE meetings, CTA/NDA submissions & approvals.
  • Prepare submission dossiers according to the latest regulation and exchange with global teams to ensure requirements are met.
  • Provide regulatory support during clinical trial site inspections and overseas on-site inspections.

Matching Summary

Responsible for the regulatory activities in Ipsen China, including license maintenance, CDE meetings, CTA/NDA submissions & approvals.

Skills & Requirements

Must-have

  • License maintenance
  • CTA/NDA submissions & approvals
  • CDE meetings preparation
  • Dossier preparation
  • QC sample management
  • Artwork creation and approval

Nice-to-have

  • Human-centric leadership
  • Collaboration and excellence
  • Empowered and thriving workplace
  • Sustainable growth focus
  • Competitor intelligence gathering

Key Requirements

  • Senior Manager level experience
  • Experience with regulatory submissions in China
  • Familiarity with Ipsen systems

Work Rights

Not specified

Tailored Resume

Cover Letter