About the jobExternal 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. API, drug substance) and finished products with minimal risk to quality or product supply.EM&S LM SC has responsibility for CMO and CLO and distribution activities related to products treating Rare Diseases and Rare Blood Disorders, Multiple Sclerosis (MS), and OncologyEM&S LM SC has offices based in Northborough and Cambridge, MA US; Frankfurt Germany;Ghent and Geel, Belgium and Amsterdam, the NetherlandsMain responsibilitiesThis function can also support to other EM&S entities than EM&S LM SCActs as a local regulatory interface between the external and internal manufacturing sites, quality units, MSAT, Global Regulatory Affairs and Sanofi affiliatesCollaborates closely with EM&S LM SC personnel in order to ensure compliant manufacturing and release operationsManages and reviews CMC (Chemistry, Manufacturing and Controls) dossiers, variations, renewals, annual reports, site registrations and territory extensions as part of regulatory product lifecycle management responsibilityReviews and approves cGMP or regulatory reports / change controls / protocols/ submissions and associated action plans in order to ensure regulatory and cGMP complianceAnalyses 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 detailsActs as a source of regulatory expertise for others and gives advice on own area to other functions and employeesSupports and ensures GMP and regulatory compliance and inspection readiness for products under ownership of EM&S LM SCSupports dossier Compliance program in compliance to Sanofi Global ProceduresSupport for Deviation and CAPAAdditional ResponsibilitiesSupport the Qualified Person in any GMP and regulatory aspects related to batch release of product, as applicableMay support internal regulatory assessment of information to support internal or external audits and supplier qualification as requiredSupport CMO compliance via GxP and regulatory documentation review and on-site visits/Person in Plant/audits if applicableFrequent inter-departmental, inter-organizational and external interactionsSupport the development and management of quality agreements between Sanofi and the contractorSupport program for maintaining performance metricsAbout youEducationBachelor’s degree with scientific background or equivalent and 5+ years of experience in a GxP or regulatory affairs environment. ORMaster’s degree with scientific background and 3 years of experience in a GxP or regulatory affairs environmentExperienceA working knowledge of conventional and biotechnological and small molecule manufacturing operations, aseptic processing, validation principles, quality control techniques and testing methodologies of drug substances and drug products is beneficialExperience within EM&S environment and/or as regulatory compliance responsible is an assetKnowledge and experience with regulatory database system (Veeva RIM) is an assetSoft and technical skillsGood understanding of quality and regulatory systems and management toolsKnowledge and experience of EU/US GMPs for the biotech/pharmaceutical industry, with an understanding of worldwide regulatory affairsDemonstrated ability to perform work that consistently requires independent decision making and the exercise of independent judgment and discretionProblem solving and technical writing skillsAbility to multitask effectivelyWillingness to travelLanguages: Good written and verbal communication in EnglishWhy choose us?Bring the miracles of science to life alongside a supportive, future-focused teamDiscover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationallyBenefit from a well-thought-out benefits package that rewards your contribution and commitmentPursue Progress. Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. Watch our ALL IN video and check out our Diversity Equity and Inclusion !Pursue Progress. Discover Extraordinary.Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law. Watch our ALL IN video and check out our Diversity Equity and Inclusion !null