External Manufacturing and Supply Large Molecule Specialty Care (EM&S LM SC) is responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs), Distribution Centers and business partners involved in the manufacture, testing, storage and transport of Sanofi products. EM&S LM SC staff interact with functional units within other Sanofi sites, and other organizations within the External Manufacturing and Supply and Specialty Care network (e.g. procurement, supply chain, finance) to ensure compliance with internal and regulatory requirements, and to disposition intermediates (e.g. Main responsibilitiesThis function can also support to other EM&S entities than EM&S LM SC
Acts as a local regulatory interface between the external and internal manufacturing sites, quality units, MSAT, Global Regulatory Affairs and Sanofi affiliates
Reviews and approves cGMP or regulatory reports / change controls / protocols/ submissions and associated action plans in order to ensure regulatory and cGMP compliance
Analyses complex regulatory issues and processes, supports to build regulatory strategic plans and applies own professional knowledge to identify key areas of risk to compliance with registered details
Supports and ensures GMP and regulatory compliance and inspection readiness for products under ownership of EM&S LM SC
Supports dossier Compliance program in compliance to Sanofi Global Procedures
Support for Deviation and CAPA
Support the Qualified Person in any GMP and regulatory aspects related to batch release of product, as applicable
May support internal regulatory assessment of information to support internal or external audits and supplier qualification as required
Support CMO compliance via GxP and regulatory documentation review and on-site visits/Person in Plant/audits if applicable
Frequent inter-departmental, inter-organizational and external interactions
Support the development and management of quality agreements between Sanofi and the contractor
Support program for maintaining performance metrics
Bachelor's degree with scientific background or equivalent and 5+ years of experience in a GxP or regulatory affairs environment. Experience within EM&S environment and/or as regulatory compliance responsible is an asset
Languages: Good written and verbal communication in English
Bring the miracles of science to life alongside a supportive, future-focused team
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally
Benefit from a well-thought-out benefits package that rewards your contribution and commitment
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