Senior Manager, Regulatory Affairs CMC

vor 4 Wochen

Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

Job Overview

The CMC Regulatory Affairs Senior Manager will be part of the Global CMC RA organization, serving as CMC RA Affiliate for assigned products and territories. This role will design and execute CMC RA strategies that align PDM's CMC objectives with Affiliate's business goals.

Key Responsibilities

  • Prepare CMC sections for all types of submissions in the product lifecycle, including investigational and commercial products, in international markets.
  • Ensure CMC parts of regulatory submissions meet ICH and regional/local regulatory requirements.
  • Perform CMC regulatory submissions, including clinical trial applications, amendments, and marketing authorizations.
  • Ensure timely discussion and negotiation with local/international health authorities regarding responses to CMC questions.
  • Perform document filing and retrieval functions, as well as workflows and procedures regarding document tracking and disseminating information to key stakeholders.
  • Perform CMC change control assessments against local regulations and guidance.
  • 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.
  • Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices.
  • Follow knowledge sharing practices using designated knowledge management tools and processes.

Requirements

  • A scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities.
  • Fluent in written and spoken English and German. Knowledge of Hebrew would be an asset.
  • Practical in-depth knowledge of ICH and EU and/or Swiss CMC regulatory requirements.
  • Proven experience with submission compilation and filing of regulatory submissions, including marketing authorization and technical variations.
  • Experience with authoring of CMC components of marketing authorization and post-approval submissions for small molecules products would be an advantage.

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