Experteer Overview
In this Regulatory Affairs Specialist role at Sanofi Spain, you will be the primary link to Spanish and EU health authorities, managing submissions and ensuring compliance across the product lifecycle. You will collaborate with cross-functional teams to align local regulatory activities with integral strategies, shaping dossiers and enabling timely launches. You’ll contribute to a patient-focused mission in a dynamic, AI-powered biopharma environment. This is a hands-on role with a meaningful impact on medicines reaching patients.

Compensaciones / Beneficios
• Ensure compliance with local and EU regulatory requirements throughout the product lifecycle
• Liaise with health authorities on submissions, requests, and interactions with timely and accurate responses
• Coordinate with global/regional regulatory teams to align local submissions with international strategy
• Provide optimal support to key stakeholders for on-time delivery of high-quality dossiers
• Maintain expertise on dossier formats, structure, navigation, and lifecycle management globally
• Review and approve promotional materials, labeling, and packaging for regulatory compliance
• Monitor changes in local regulatory legislation and communicate impact to stakeholders




• Support new product launches by developing and executing local regulatory strategies and timelines
• Maintain regulatory databases and tracking systems, ensuring audit-ready documentation
• Collaborate cross-functionally with Quality, Medical, Pharmacovigilance, and Marketing
• Contribute to internal audits and health authority inspections as regulatory SME

Responsabilidades
• Bachelor's or Master's in Pharmacy, Chemistry, Biology, or related Life Sciences
• Established experience in Regulatory Affairs within the pharmaceutical industry (Iberia market experience preferred)
• Solid knowledge of Spanish (AEMPS) regulatory frameworks and EU pharmaceutical legislation
• Fluency in Spanish and English; Portuguese is a plus
• Organizational and time-management skills
• Ability to manage multiple projects and deadlines in a fast-paced, cross-functional environment
• Excellent communication and stakeholder management skills
• Proactive, solution-oriented mindset with strong problem-solving abilities
• Experience with regulatory software/tools (e.g., Veeva RIM, similar systems) is a plus

Requisitos principales
• salary range
• employee benefit programs
• equal opportunities
• diversity and inclusion actions

📌 Regulatory Affairs Specialist (Madrid)
🏢 Sanofi
📍 Madrid