Senior Manager, Regulatory Affairs CMC

5 hours ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time
Job Title: Senior Manager, Regulatory Affairs CMC

Job Summary:

The CMC Regulatory Affairs International Affiliate Team at Gilead Sciences International, Ltd. is seeking a highly motivated and experienced Senior Manager to join our team in Cambridge, United Kingdom. As a key member of our Global CMC RA organization, you will serve as CMC RA Affiliate for assigned products and territories, designing and executing CMC RA strategies that align PDM's CMC objectives with Affiliate's business goals.

Key Responsibilities:
  • Ensure CMC part of the regulatory submissions meets ICH and regional/local regulatory requirements.
  • Perform CMC regulatory submissions, including clinical trial applications, amendments, supplements, marketing authorizations, post-approval variations, periodic reports, and license renewals.
  • Ensure timely discussion and negotiation with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses.
  • Perform document filing and retrieval functions, as directed, or with departmental SOPs and work instructions.
  • Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
  • Perform CMC change control assessments against local regulations, guidance, and best practices.
  • Frequently interact and collaborate with colleagues outside of CMC RA to define strategy and filing plans.
  • Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms.
  • Contribute to regulatory strategy and filings outside of the assigned market(s).
  • Contribute to local/regional/global process improvements, which have an impact on the working of the CMC Regulatory Affairs function or other functional areas.
  • Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices.
  • Follow knowledge sharing practices using designated knowledge management tools and processes.
  • Understand and guide relevant stakeholders and project teams on potential or actual impact of regional/local circumstances.
  • Ensure regulatory conformance and consistency for assigned products in compliance with regulatory requirements and internal procedures.
  • Ensure CMC changes with impact on labeling are communicated to the relevant stakeholders responsible for preparation and maintenance of country-specific labeling.
Requirements:
  • A scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities.
  • Practical in-depth knowledge of ICH and EU and/or UK CMC regulatory requirements.
  • Proven experience with submission compilation and filing of regulatory submissions, including marketing authorization and technical variations of different complexity in EU and/or in UK.
  • Experience with authoring of CMC components of marketing authorization and post-approval submissions for small molecules products.
  • Experience representing CMC regulatory affairs on regulatory and cross-functional teams.
  • Participation and contribution to Health Authority interactions.
What We Offer:

Gilead Sciences International, Ltd. is an equal employment opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

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