EU Platform Coordinator (H/F)

About the job As EU Platform Coordinator VIE within our EU Platform team and with permanent interactions with the Regulatory Strategists (RS) and the regulatory affiliates contacts, you will execute regional regulatory related activities in support of maintenance and administrative regulatory activities for Sanofi products for direct & deferred action countries. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. Ready to get started? About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main responsibilities: - Deliver key start and follow-up of submissions, Initial/HA Request for Supplementary Information as per plan/requests for Sanofi products including European procedures (Worksharing, MRP/DCPs & CPs) and for deferred action countries following the approval of EU reference countries. - Apply corresponding operational model set up by Partner Market EU (PME) team or Swiss affiliate & follow the corresponding WoWs and training materials associated. - Include coordination of administrative and regulatory activities related to administrative changes, Marketing Authorisation Transfer (MAT), Orphan Drug Designation (ODD), Pediatric Investigational Plan (PIP) and RPI (Research Product Identification) transfers. - Apply simplification of the end-to-end processes leading to limit contribution of RS and affiliates and retrieve information from regulatory database and regional regulations. - Participate in the maintenance and improvements of the current regulatory repositories already in place. - Ensure with contributors the process compliance and timeliness. - Enter associated data into Sanofi systems as required by internal SOPs and policies (#BeDataReady) in case of EU-Platform coordination and/or restricted access for EU deferred countries. - Participate in the preparation and update of quality document, processes, tool enhancement and training materials pertaining to role. - Monitor KPI’s by running reports, collating data and report as per oversight and governance process. - Use regulatory business data knowledge, understanding of system data model(s) and technical skills, analysis requirements and specifications for regional regulatory information, reports, and analytics. Why choose us? - Be part of a pioneering biopharma company where patient insights shape drug development. - Work at the forefront of AI-powered science that accelerates discovery and improves outcomes. - Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams. - Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. - Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. - Help improve the lives of millions of people globally by making drug development quicker and more effective. iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow. Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work. Pursue Progress. Discover Extraordinary. 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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

About you Experience: - Previous experience in EU regulatory affairs department in a global pharmaceutical company is preferred. - Experience working in a highly matrixed, multifunctional and multicultural organization. - Experience with the management of activities requiring short to long term planning and monitoring ability. - Experience with project management and driving deliverables to completion is an asset. Soft and technical skills: - Proactivity, great communication skills, good stakeholder management skills. - Comprehensive knowledge and operational expertise of the EU regulations and procedures is preferred. - Understanding of the relationship between systems and electronic databases, understanding of eCTD dossier requirements and the change management in the pharmaceutical area and EMA vision of digital interfaces would be an asset. - Knowledge of tracking regulatory activities in corporate database. Education: - Master’s Degree in Science, Regulatory Affairs or similar field. Languages: - Fluency in English. To facilitate the examination of your application by our English-speaking managers, thank you for applying in English.

La volonté de faire progresser la science nous unit. En France, nous sommes plus de 20 000 hommes et femmes passionnés. L’innovation est un parcours inattendu de défis. Alors, sans relâche, nous repoussons nos limites pour transformer la pratique de la médecine et améliorer la santé des patients avec nos médicaments et vaccins.