Regulatory Affairs Manager Spain at Opella Healthcare UK Limited

Barcelona, Catalonia, Spain -

Full Time

Start Date

Immediate

Expiry Date

02 Oct, 26

Salary

0.0

Posted On

04 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Marketing Authorisations, Compliance Management, Labelling, Regulatory Intelligence, Veeva RIM, GxP, Quality Management Systems, English Fluency, Spanish Fluency, Catalan Fluency, Interpersonal Skills, Cross-functional Collaboration, Stakeholder Management

Industry

Retail Health and Personal Care Products

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 Manager 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: Define and execute regulatory strategies to secure and maintain marketing authorisations in Spain Manage end-to-end submissions (registrations, variations, renewals, safety updates) ensuring compliance and quality Oversee labelling and prescribing information updates across the product portfolio Lead interactions and negotiations with Spanish regulatory authorities and notified bodies Collaborate cross-functionally (Supply Chain, Medical, PV, Quality, Commercial) to support business continuity and compliance Provide regulatory intelligence by monitoring EU/Spanish legislation and advising stakeholders on impact Drive process excellence by optimising regulatory systems (e.g., Veeva RIM), improving SOPs, and supporting KPIs 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 5-7 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 home based 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. #LI-HYBRID 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.

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Responsibilities

The role involves defining and executing regulatory strategies to secure and maintain marketing authorisations for OTC medicines, food supplements, and medical devices in Spain. It also requires managing end-to-end submissions and leading interactions with Spanish regulatory authorities and notified bodies.