Regulatory Submission Manager - Regulatory Affairs Officer

Roche UK

Multiple Locations
Ectd specifications and validation
Ectd publishing process and tools
Regulatory agency requirements
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally

Job Summary

  • Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
  • The Position requires solid knowledge of regulatory agency requirements for electronic submissions format and delivery including profuse knowledge of eCTD specifications and validation requirements.
  • 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

Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.

Skills & Requirements

Must-have

  • eCTD specifications and validation
  • eCTD publishing process and tools
  • regulatory agency requirements
  • electronic submissions format and delivery
  • assembly, formatting, publishing, submissions

Nice-to-have

  • personal expression and open dialogue
  • collaboration and strong relationships
  • continuous learning and self-improvement
  • digital mindset and IT proficiency

Key Requirements

  • > 3 years’ experience in Pharma MNCs
  • at least 2 years in regulatory submissions
  • Experience in delivering eCTD submissions
  • Independent working
  • B.S. or above in Pharmacy, Medical, Biology

Work Rights

Not specified

Tailored Resume

Cover Letter