Regulatory Affairs Manager Spain

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. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com. 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 Why us? At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day. We Are Challengers. We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things: All In Together: We keep each other honest and have each other's backs. Courageous: We break boundaries and take thoughtful risks with creativity. Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity. Radically Simple: We strive to make things simple for us and simple for consumers, as it should be. Opella values diversity in all its forms and is committed to fostering a workplace where everyone can belong and excel. We welcome and encourage applications from people of all backgrounds. Join us on our mission. Health. In your hands. www.opella.com/en/careers LI-HYBRID