Sanofi
Regulatory Affairs Manager Spain
Salary
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 authorities and notified bodies
Cross-Functional Collaboration
- Partner with Supply Chain, Medical Affairs, Pharmacovigilance, Quality, and Commercial teams to support business continuity
- Collaborate with global regulatory teams to align local strategies with international objectives
- Contribute to promotional material review ensuring regulatory compliance
- Support risk-minimisation activities and safety communications
Regulatory Intelligence & Process Excellence
- Monitor and interpret Spanish and EU regulatory legislative changes, advising internal stakeholders on business impact
- Maintain and optimise regulatory databases and systems (e.g., Veeva RIM)
- Drive continuous process improvements and contribute to SOP development
- Support departmental KPIs and regulatory performance metrics
What You'll Gain
Impact: Shape regulatory strategy for Spain's consumer healthcare market
Growth: Develop expertise in a diverse, purpose-driven environment
Innovation: Work with cutting-edge products and emerging regulatory frameworks
Community: Join a team where curiosity and ideas drive meaningful change
About you:
Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, or related scientific discipline
Regulatory affairs experience of 3-5 years within a pharmaceutical company, with responsibility for CHC products
Knowledge of EU and Spanish regulatory farmeworks, including national and european procedures
Understanding of the local Consumer Healthcare regulatory environment and market-specific requirements
Experience with regulatory information management systems (Veeva RIM or similar platforms)
Familiarity with GxP requirements and quality management systems
Fluent in English, Spanish, and Catalan is a must have.
A challenger mindset, good communication and interpersonal skills, collaborative mindset and team spirit.
Job location: Barcelona
Remote working policy: 2 days/week
This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella.
About Us:
Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
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