Associate Director, Regulatory Operations, Europe

Revolution Medicines

Basel, Switzerland
**
8+ years regulatory operations experience
Ectd submission publishing expertise
Veeva vault rim hands-on experience
** Revolution Medicines is seeking an Associate Director of Regulatory Operations in Basel, Switzerland, to lead the operational planning and execution of regulatory submissions across Europe. The ideal candidate will have extensive experience in regulatory affairs within the biotechnology or pharmaceutical industries, focusing on delivering high-quality regulatory submissions to health authorities. **

Job Summary

  • This role supports the European Regulatory Affairs organization by leading operational planning and execution of regulatory submissions across the region.
  • The successful candidate will manage detailed timelines, coordinate cross-functional teams, and ensure high-quality submissions to authorities like EMA, MHRA, and Swissmedic.
  • Candidates must have hands-on experience with Veeva Vault RIM and DocuBridge for preparing and publishing eCTD submissions in compliance with global standards.

Matching Summary

Match Score: 75

** Revolution Medicines is seeking an Associate Director of Regulatory Operations in Basel, Switzerland, to lead the operational planning and execution of regulatory submissions across Europe. The ideal candidate will have extensive experience in regulatory affairs within the biotechnology or pharmaceutical industries, focusing on delivering high-quality regulatory submissions to health authorities. **

Skills & Requirements

Must-have

  • 8+ years regulatory operations experience
  • eCTD submission publishing expertise
  • Veeva Vault RIM hands-on experience
  • DocuBridge regulatory publishing skills
  • European health authority submission knowledge

Nice-to-have

  • Oncology or rare disease regulatory experience
  • Experience managing external publishing vendors
  • Familiarity with EU SPOR/IDMP data standards
  • Global regulatory team collaboration experience

Key Requirements

  • Bachelor's degree in life sciences
  • 8+ years in biotech/pharma regulatory operations
  • Proven eCTD submission management capability

Work Rights

Not specified

Tailored Resume

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