EM&S Turkey Regulatory Affairs Officer

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 Management• Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs
• Coordinate the regulatory compliance exercise with the assigned Hub
• Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)
• Support the preparation, maintenance, and update of CMC dossiers for assigned products
• Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites
• Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs…)
• Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities

• Regulatory Interface & Submissions Support• Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub
• Consolidate industrial and technical data required for local and regional registrations and variations
• Support responses to Health Authority requests (RFI, deficiency letters)
• Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines
• Perform 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 management
• Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams
• Prepare the Variation Record Card (VRC) for product divestments

• Site Compliance & Regulatory Maintenance• Compile 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 renewals
• Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities
• Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures

• HSE & Compliance Awareness• Ensure compliance with applicable HSE rules and procedures
• Report accidents and incidents occurring in the workplace in line with internal requirements
• Support site and Quality initiatives promoting compliance and quality culture (Quality Day)

• Compliance & Ethics• Comply with the Company's Code of Ethics, upholding high professional standards of conduct
• Demonstrate a commitment to protecting and enhancing the Company's reputation
• Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role
• Apply 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 field
• Experience: 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 effectively
• Experience in management of change control with regulatory impact

• Skills: • Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)
• Understanding of CMC dossiers, variations, and product lifecycle management
• Familiarity with External Manufacturing / CMO environments is a plus
• Working knowledge of Quality Systems (Change Control, CAPA)
• Ability to compile, review, and manage technical and regulatory documentation
• Comfortable 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.

#LI-EUR

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