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Regulatory Affairs Senior Manager

2 months ago

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

About the Role

Gilead Sciences International, Ltd. is seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our CMC Regulatory Affairs International Affiliate Team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to align with our business goals.

Key Responsibilities

  • Ensure CMC regulatory submissions meet ICH and regional/local regulatory requirements.
  • Perform CMC regulatory submissions, including clinical trial applications, amendments, and marketing authorizations.
  • Collaborate with international/local colleagues to ensure consistency of responses to health authority questions.
  • Develop and implement risk-based approaches to mitigate regulatory risks.
  • Contribute to global filing strategy and provide local/regional expertise in CMC regulatory requirements.
  • Perform regulatory intelligence and stay up-to-date with current global, regional, and local trends in CMC Regulatory Affairs.

Requirements

  • Scientific degree with directly relevant professional experience in CMC regulatory activities.
  • Practical knowledge of ICH and EU/UK CMC regulatory requirements.
  • Proven experience with submission compilation and filing of regulatory submissions.
  • Excellent communication and negotiation skills.
  • Ability to work independently and as part of a team.

About Gilead Sciences International, Ltd.

Gilead Sciences International, Ltd. is a global biopharmaceutical company dedicated to delivering innovative therapies to patients with life-threatening diseases. We are committed to diversity, equity, and inclusion in our workplace and strive to create a culture that values and respects all employees.