JobMesh

Regulatory Affairs Manager Spain

Sanofi · Barcelona, Catalonia, ES

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leade...

Job description

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Regulatory Affairs Manager , you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human. About the job: We are seeking a dynamic Regulatory Affairs Specialist to shape Spain’s regulatory strategy and ensure seamless access for our Consumer Healthcare portfolio. You will be the strategic driver behind obtaining and mantaining marketing authorisations for OTC medicines, food supplements and medical devices across Spain. Main responsibilities: Submissions & Compliance Management - Develop and execute comprehensive regulatory strategies to obtain and maintain marketing authorisations in Spain - Manage end-to-end regulatory submissions including new registrations, variations, renewals, and safety updates - Ensure timely, high-quality submissions that meet all regulatory requirements - Oversee labelling compliance and prescribing information updates across the product portfolio - Lead interactions and negotiations with Spanish regulatory author...