Senior Manager, Regulatory Affairs CMC

vor 1 Monat

Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit
Job Title: Senior Manager, Regulatory Affairs CMC

Gilead Sciences Switzerland Sarl is seeking a highly skilled and experienced Senior Manager, Regulatory Affairs CMC to join our team in Zug, Switzerland.

Job Summary:

The CMC Regulatory Affairs Senior Manager will be responsible for leading the development and implementation of regulatory strategies for CMC activities in Switzerland and Israel. This role will involve preparing and submitting regulatory documents, ensuring compliance with ICH and regional/local regulatory requirements, and collaborating with cross-functional teams to achieve business objectives.

Key Responsibilities:
  • Prepare and submit CMC sections for regulatory submissions, including marketing authorization and technical variations.
  • Ensure CMC regulatory submissions meet ICH and regional/local regulatory requirements.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies.
  • Perform document filing and retrieval functions, and maintain document tracking and indexing systems.
  • Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms.
  • Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices.
Requirements:
  • Scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities.
  • Fluent in written and spoken English and German, with knowledge of Hebrew 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.
What We Offer:

Gilead Sciences Switzerland Sarl offers a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to diversity and inclusion, and welcome applications from qualified candidates from diverse backgrounds.

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