Regulatory Affairs Officer - Submission Management

Roche UK

Multiple Locations, United Kingdom
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Ectd specifications and validation
Ectd publishing process and tools
Regulatory agency requirements
** Roche UK is seeking a Regulatory Affairs Officer with expertise in eCTD submissions and a strong background in regulatory requirements for electronic formats. The ideal candidate will have over three years of experience in the pharmaceutical industry, excellent communication skills, and a commitment to continuous learning. **

Job Summary

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

Match Score: 75

** Roche UK is seeking a Regulatory Affairs Officer with expertise in eCTD submissions and a strong background in regulatory requirements for electronic formats. The ideal candidate will have over three years of experience in the pharmaceutical industry, excellent communication skills, and a commitment to continuous learning. **

Skills & Requirements

Must-have

  • eCTD specifications and validation
  • eCTD publishing process and tools
  • regulatory agency requirements
  • electronic submissions format and delivery
  • collaboration with diverse stakeholders
  • interpersonal and communication skills

Nice-to-have

  • RIM/Veeva Vault systems experience
  • crisis management experience
  • sensitivity to regulation change
  • opportunities for process improvement

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter