Regulatory Affairs Senior Manager

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Senior Manager to join our team at Gilead Sciences International, Ltd. in Cambridge, United Kingdom.

Job Summary

The successful candidate will be responsible for leading the development and implementation of regulatory strategies for CMC (Chemistry, Manufacturing, and Controls) activities in the UK market. This role requires a deep understanding of ICH and EU/UK regulatory requirements, as well as excellent communication and negotiation skills.

Key Responsibilities
  • Ensure compliance with ICH and regional/local regulatory requirements for CMC submissions
  • Develop and implement risk-based approaches to mitigate regulatory risks
  • Collaborate with cross-functional teams to ensure consistency of responses to health authorities
  • Author and submit responses to health authorities with a sense of urgency
  • Perform document filing and retrieval functions
  • Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms
Requirements
  • A scientific degree with directly relevant professional experience in small molecules CMC regulatory activities
  • Practical in-depth knowledge of ICH and EU/UK CMC regulatory requirements
  • Proven experience with submission compilation and filing of regulatory submissions
  • Excellent organizational skills and ability to work on multiple products/markets simultaneously
Benefits

We offer a competitive salary of approximately £65,000 - £80,000 per annum, depending on experience, plus benefits including health insurance, pension scheme, and generous holiday allowance.



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