CMC Regulatory Affairs Expert
Vor 4 Tagen
About the Role
Gilead Sciences Switzerland Sarl is seeking a motivated and experienced CMC Regulatory Affairs Expert to join our team in Zug, Switzerland.
Job Summary
The CMC Regulatory Affairs International Affiliate Team is looking for a skilled professional to assume a full-time employment position in the capacity of CMC Regulatory Affairs Manager, reporting to the CMC Regulatory Affairs International Affiliate Team Leader.
Key Responsibilities
- Prepare the CMC sections for all types of submissions in the product lifecycle, for a range of investigational and commercial products, including small molecules and biologics, in international markets.
- 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 as necessary, 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, document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
- 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.
- Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices, assessing impact on the current and future fillings.
- 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 (biologics experience would be an advantage), of at least 8 years with a Bachelor of Science or 6 years with a Master of Science.
- 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, and an understanding of current global, regional, and local trends in CMC Regulatory Affairs.
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