Regulatory Strategist (H/F)

About the job As Regulatory Strategist VIE within our General Medicines team, you’ll be a key member of the GRT, and strategic partner to the GRL, and will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions. You will also provide regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives. Join the team transforming how healthcare is delivered for chronic and specialty conditions worldwide. In General Medicines, you’ll help drive meaningful outcomes in diabetes, transplant, and immunology - with the scale and urgency patients deserve. 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: - Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and Global Regulatory Team for assigned projects. - Liaises with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes. - Contributes to the Global Regulatory Team (GRT) for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings. - May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in their remit, as needed. - Identifies regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardized methodologies as appropriate. - Contributes to the development of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of products. - Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations. - Ensure that respective regulatory team members have the information necessary to contribute to the development and execution of the Global Regulatory Strategy for their responsible accountabilities. - Accountable for developing the Health Authority engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself. - Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management. - Accountable for complete and accurate communication/interaction (including tracking) with the relevant HAs for the projects/products in their remit. 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. - Help shape the future of care for chronic and complex conditions like aT1D, Type 2 diabetes, transplant, and cardiovascular disease. - Drive meaningful impact at global scale: our medicines reach more than 100 million people each year. - Turn bold ideas into breakthrough launches, with multiple new therapies planned through 2030 and beyond. 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: - Minimum 1 year of full-time relevant experience. Soft and technical skills: - Strong interest in Regulatory Affairs. - Proficient in the use of MS Word, PowerPoint, Excel, and collaborative work environment tools (eg. SharePoint). - Ability to work in electronic document management systems, e.g., Veeva vault is a plus. - Rigor, adaptability, team spirit. - Strong sensitivity for a multicultural/multinational environment. Education: - Master’s Degree in Pharmacy, Life Science or other related 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.