Regulatory Affairs Manager – Spain

About the role

Opella is seeking a Regulatory Affairs Manager to lead the regulatory strategy for its consumer healthcare portfolio in Spain. You will be responsible for securing and maintaining marketing authorisations for OTC medicines, food supplements, and medical devices, ensuring that products reach the market efficiently and compliantly.

Key responsibilities

• Define and execute regulatory strategies to obtain and maintain marketing authorisations in Spain.
• Manage end‑to‑end submissions, including registrations, variations, renewals, and safety updates.
• Oversee labelling and prescribing information updates across the product portfolio.
• Lead interactions and negotiations with Spanish regulatory authorities and notified bodies.
• Collaborate with Supply Chain, Medical, PV, Quality, and Commercial teams to support business continuity.
• Provide regulatory intelligence by monitoring EU and Spanish legislation.
• Drive process excellence by optimising regulatory systems (e.g., Veeva RIM) and improving SOPs.

Required profile

• Bachelor’s degree or higher in Pharmacy, Chemistry, Biology, Life Sciences or related field.
• 5‑7 years of regulatory affairs experience within a pharmaceutical company, focusing on consumer healthcare products.
• In‑depth knowledge of EU and Spanish regulatory frameworks and local market requirements.
• Fluent in English, Spanish and Catalan.
• Strong communication, collaborative mindset and challenger attitude.

Required skills

• Veeva RIM or similar regulatory information management system.
• GxP requirements and quality management systems.

What we offer

• Opportunity to shape regulatory strategy for Spain’s consumer healthcare market.
• Exposure to innovative OTC and supplement products.
• Hybrid work model with two days per week remote.
• Dynamic, purpose‑driven environment focused on health impact.