Regulatory Affairs Officer - Submission Management

Roche UK

Ectd specifications and validation
Ectd publishing process and tools
Veeva vault systems experience
At Roche you can show up as yourself, embraced for the unique qualities you bring

Job Summary

  • At Roche you can show up as yourself, embraced for the unique qualities you bring.
  • The Position requires eCTD Expertise including solid knowledge of regulatory agency requirements for electronic submissions format and delivery.
  • A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come.

Matching Summary

At Roche you can show up as yourself, embraced for the unique qualities you bring.

Skills & Requirements

Must-have

  • eCTD specifications and validation
  • eCTD publishing process and tools
  • Veeva Vault systems experience
  • Regulatory agency requirements
  • Stakeholder collaboration and negotiation

Nice-to-have

  • Personal expression and open dialogue
  • Continuous learning and self-improvement
  • Proactive process improvement identification
  • Fostering a collaborative work environment

Key Requirements

  • > 3 years’ experience in Pharma MNCs
  • at least 2 years in regulatory submissions
  • Experience in delivering eCTD submissions
  • B.S. or above in Pharmacy, Medical, Biology
  • Chinese (mother-tone level) and English (proficiency level)

Work Rights

Not specified

Tailored Resume

Cover Letter