EM&S Turkey Regulatory Affairs Officer

Location: Istanbul

About the job

Reporting to the EM&S Middle East Quality Manager, the Regulatory Affairs Officer supports regulatory compliance and lifecycle activities related to External Manufacturing & Supply operations. The role ensures alignment between regulatory dossiers and industrial practices at CMO, in compliance with local regulations and Sanofi standards, and acts as a key interface between Affiliate Regulatory Affairs and CMO.

This position contributes to the implementation of Sanofi’s Quality and Regulatory policies within External Manufacturing & Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.

Main responsibilities:

Regulatory Compliance & Lifecycle ManagementEnsure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOsCoordinate the regulatory compliance exercise with the assigned HubMaintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)Support the preparation, maintenance, and update of CMC dossiers for assigned productsAssess the regulatory impact of proposed changes (change controls) originating from CMO or internal sitesSupport Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs…)Contribute to the implementation of Sanofi Quality policy across External Manufacturing activitiesRegulatory Interface & Submissions SupportAct as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the HubConsolidate industrial and technical data required for local and regional registrations and variationsSupport responses to Health Authority requests (RFI, deficiency letters)Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelinesPerform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP…)Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation managementSupport regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teamsPrepare the Variation Record Card (VRC) for product divestmentsSite Compliance & Regulatory MaintenanceCompile and maintain product specification files and support updates of the Site Master File (SMF)Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewalsParticipate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activitiesContribute to continuous improvement initiatives related to Regulatory Affairs processes and proceduresHSE & Compliance AwarenessEnsure compliance with applicable HSE rules and proceduresReport accidents and incidents occurring in the workplace in line with internal requirementsSupport site and Quality initiatives promoting compliance and quality culture (Quality Day)Compliance & EthicsComply with the Company's Code of Ethics, upholding high professional standards of conductDemonstrate a commitment to protecting and enhancing the Company's reputationMaintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the roleApply ethical principles and governance standards to all work activities

About you

Education: Bachelor’s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific fieldExperience: At least 5 years’ experience in the pharmaceutical industry, preferably with 2 years+ in a similar role, working in a regulatory team.Proven ability to manage multiple priorities effectivelyExperience in management of change control with regulatory impactSkills: Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)Understanding of CMC dossiers, variations, and product lifecycle managementFamiliarity with External Manufacturing / CMO environments is a plusWorking knowledge of Quality Systems (Change Control, CAPA)Ability to compile, review, and manage technical and regulatory documentationComfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)Languages: Fluency in English is required, knowledge of other languages is an asset

Why choose us?

Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.

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