EM&S Turkey Regulatory Affairs Officer

<p><i>EM&amp;S Turkey Regulatory Affairs Officer</i></p><ul><li><i>Location:</i> <i>Istanbul</i></li></ul><p></p><p><i>About the job</i></p><p></p><p>Reporting to the EM&amp;S Middle East Quality Manager, the <b>Regulatory Affairs Officer</b> supports regulatory compliance and lifecycle activities related to External Manufacturing &amp; 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.</p><p></p><p>This position contributes to the implementation of Sanofi’s Quality and Regulatory policies within External Manufacturing &amp; Supply activities, ensuring regulatory compliance of manufactured products, supporting product lifecycle management, and enabling timely execution of regulatory-impacting changes and transfers.</p><p></p><p><b>Main responsibilities:</b></p><ul><li><b>Regulatory Compliance &amp; Lifecycle Management</b><ul><li>Ensure regulatory compliance between CMC dossiers / Marketing Authorizations and manufacturing practices at CMOs</li><li>Coordinate the regulatory compliance exercise with the assigned Hub</li><li>Maintain regulatory compliance of manufactured products throughout their lifecycle (variations, renewals, annual updates)</li><li>Support the preparation, maintenance, and update of CMC dossiers for assigned products</li><li>Assess the regulatory impact of proposed changes (change controls) originating from CMO or internal sites</li><li>Support Product Registration Renewals and periodic regulatory submissions (Annual Reports, PQRs…)</li><li>Contribute to the implementation of Sanofi Quality policy across External Manufacturing activities</li></ul></li><li><b>Regulatory Interface &amp; Submissions Support</b><ul><li>Act as the regulatory interface between Affiliate Regulatory Affairs, site Regulatory teams, CMOs, and the Hub</li><li>Consolidate industrial and technical data required for local and regional registrations and variations</li><li>Support responses to Health Authority requests (RFI, deficiency letters)</li><li>Monitor submission and approval status and ensure appropriate communication of regulatory approvals and implementation timelines</li><li>Perform regulatory review and approve documentation provided by the Hub prior to submission while ensuring documentation management within Sanofi systems (Veeva Vault)</li><li>Manage regulatory activities in Veeva Vault (Regulatory Objective, SCP…)</li><li>Participate in Quality System activities, including Change Control, CAPA, PQR, training, and documentation management</li><li>Support regulatory aspects of technology transfers, product transfers, and site projects in collaboration with Quality, Supply Chain, and Project teams</li><li>Prepare the Variation Record Card (VRC) for product divestments</li></ul></li><li><b>Site Compliance &amp; Regulatory Maintenance</b><ul><li>Compile and maintain product specification files and support updates of the Site Master File (SMF)</li><li>Support the maintenance of manufacturing licenses, GMP certificates, site registrations, and renewals</li><li>Participate in internal audits, external audits, and regulatory inspections, supporting preparation and follow-up activities</li><li>Contribute to continuous improvement initiatives related to Regulatory Affairs processes and procedures</li></ul></li><li><b>HSE &amp; Compliance Awareness</b><ul><li>Ensure compliance with applicable HSE rules and procedures</li><li>Report accidents and incidents occurring in the workplace in line with internal requirements</li><li>Support site and Quality initiatives promoting compliance and quality culture (Quality Day)</li></ul></li><li><b>Compliance &amp; Ethics</b><ul><li>Comply with the Company&#39;s Code of Ethics, upholding high professional standards of conduct</li><li>Demonstrate a commitment to protecting and enhancing the Company&#39;s reputation</li><li>Maintain comprehensive knowledge of regulatory guidance, technical developments, ethics, and governance requirements relevant to the role</li><li>Apply ethical principles and governance standards to all work activities</li></ul></li></ul><p></p><p><i>About you </i></p><ul><li><b>Education:</b> Bachelor’s degree or higher in Pharmacy, Chemistry, Microbiology, Quality, or a related scientific field</li><li><b>Experience:</b> At least 5 years’ experience in the pharmaceutical industry, preferably with 2 years&#43; in a similar role, working in a regulatory team.<ul><li>Proven ability to manage multiple priorities effectively</li><li>Experience in management of change control with regulatory impact</li></ul></li><li><b>Skills: </b><ul><li>Good knowledge of pharmaceutical regulatory requirements (EU and local regulations)</li><li>Understanding of CMC dossiers, variations, and product lifecycle management</li><li>Familiarity with External Manufacturing / CMO environments is a plus</li><li>Working knowledge of Quality Systems (Change Control, CAPA)</li><li>Ability to compile, review, and manage technical and regulatory documentation</li><li>Comfortable using digital tools (Excel, PowerPoint, and regulatory document management systems)</li></ul></li><li><b>Languages:</b> Fluency in English is required, knowledge of other languages is an asset</li></ul><p></p><p><i>Why choose us?</i></p><ul><li>Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.</li><li>Be part of an organization that invests in people, technology, and sustainability, leading the industry in low-carbon manufacturing and digital transformation.</li></ul><p></p><p>#LI-EUR</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.</p><p></p><p>At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p>