Global Regulatory Affairs Clinical Trials Coordinator (H/F)

About the job As Global Regulatory Affairs Clinical Trials Coordinator VIE within our Global Regulatory Affairs team, you’ll manage regulatory activities related to Clinical Trials Applications, from planning and dossier preparation, then submission, responses to Health Authorities and approvals of Trials. We are developing our knowledge in Clinical Trial Applications (CTA) related Intelligence, in particular our knowledge in the European Clinical Trial Regulation. Your work will support knowledge development, and field experience for the European Clinical Trial Regulation processes. 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: - Provide regulatory expertise to Sanofi key stakeholders and help teams understand and follow important healthcare regulations. - Set up processes and coordinate the preparation of Clinical Trial Applications (CTAs). - Work closely with different departments including Research & Development (R&D), Clinical Operations, and Pharmacovigilance teams. - Ensure all documentation meets quality standards. - Monitor the progress of CTAs through submission and approval stages. - Identify potential issues early and develop practical solutions, keep projects moving forward on schedule and drive process improvement. - Help implement new regulatory processes (Clinical Trial Regulation in Europe, EU Clinical Data Disclosure). - Contribute to developing more efficient ways of working, stay current with changing regulations and help teams adapt. 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. - 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. - Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice. 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 pharmaceutical industry in Regulatory Affairs or similar field. - Clinical Trial Regulations experience is highly preferred. Soft and technical skills: - Good communication & negotiation skills. - Proactiveness, and problem-solving ability. - Ability to work with cross-functional teams. - Ability to handle multiple tasks and projects simultaneously. Education: - Master’s Degree in Pharmacy, or other relevant scientific field. Languages: - Fluency in English (written and verbal). - Italian knowledge would be an asset. 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.