Regulatory Affairs Manager

08 ago - Milano
Sanofi

**Regulatory Affairs Manager**: - Location: Milan - Italy **About the job**:
As Regulatory Affairs Manager within our Italian Regulatory Affairs, you’ll provide strategic and technical advice at the highest level in the company. In this way, the team make a significant contribution, both commercially and scientifically, to the success of a development programs. Ready to get started? Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. **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 to GRA input for marketed products and contribute on the efficient preparation of the regulatory submission and/or any type of responses document to Health Authority questions in strict cooperation with GRA and other functions (Medical, Pharmacovigilance, etc.);
- Ensure maintenance and compliance of regulatory activities for existing products;
- Ensure that Marketing Authorizations,



product packaging and associated information are updated in accordance with the current product licenses and in line with new safety information in a timely manner and inspection readiness;
- Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national and European regulations;
- Highlight compliance issues with all products within the portfolio and make proposals for their resolution;
- Maintain a good relationship cooperating with all the other Company functions;
- Follow regulatory changes and assess potential impact on daily activities. **About you**: - ** Experience**: significant and proven experience in Regulatory Affairs;
- ** Soft and technical skills**: Flexibility, resilience, active learning, coordination skills, reading comprehension, team working, problem solving; Regulatory knowledge, analytical skills, time management, presentation skills, write-right;
- ** Education**: Scientific Degree;
- ** Languages**: Fluent Italian and English - written and speaking. **Why choose us?**: - Make your work count by supporting a company that brings life-changing treatments to millions — and is committed to doing right by patients, communities, and the planet;
- Drive progress from within by helping simplify, scale, and modernize how a global biopharma business delivers smarter, faster, and more sustainably;
- Support teams across science, medicine, and operations by building better systems, shaping bold strategies, and enabling innovation at speed;
- Make an impact across borders and functions, collaborating with leaders to turn complex challenges into real-world solutions. LI-EUR LI-Hybrid null

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