Job title : Regulatory Affairs Specialist
Location: Madrid
Job type:
Fixed-term , Full time
About the job Join Sanofi's Regulatory Affairs team in Spain and play a pivotal role in bringing innovative medicines to patients while ensuring full compliance with local and EU regulatory requirements. As our Regulatory Affairs Specialist, you will act as the key liaison with Spanish and European health authorities, managing submissions and interactions with precision and timeliness. This role offers the opportunity to be a true regulatory expert — shaping submissions, safeguarding compliance, and driving impact across the full product lifecycle in a dynamic, patient-focused environment.
Join the engine of Sanofi’s mission — where deepimmunosciencemeets bold, AI-powered research. In R&D;, you’ll drive breakthroughs thatcouldturn the impossible intopossible formillions.
About Sanofi We’re an R&D-driven;, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities
Ensure compliance with local and EU regulatory requirements throughout the product lifecycle
Liaise with health authorities on submissions, requests and other interactions, ensuring timely and accurate response
Coordinate with general/regional regulatory affairs teams to align local submissions with international regulatory strategy
Secure optimal support to key stakeholders for on-time delivery of high quality dossiers in compliance with Health Authority requirements.
Expertise on all dossier formats, structure, navigation, and life cycle management globally
Review and approve promotional materials, labeling, and packaging for regulatory compliance
Monitor changes in local regulatory legislation and communicate impact to relevant internal stakeholders
Support new product launches by developing and executing local regulatory strategies and timelines
Maintain regulatory databases and tracking systems, ensuring documentation is audit-ready
Collaborate cross-functionally with Quality, Medical, Pharmacovigilance, and Marketing departments
Contribute to internal audits and health authority inspections as regulatory subject matter expert
About you
Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related Life Sciences field
Established experience in Regulatory Affairs within the pharmaceutical industry (Iberia market experience preferred)
Solid knowledge of Spanish (AEMPS) regulatory frameworks and EU pharmaceutical legislation. Knowledge of Portuguese (INFARMED) framework would be a plus
Fluency in Spanish and English required; 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
Why choose us?
Be part of a pioneeringbiopharmacompany that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
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📌 Regulatory Affairs Specialist (Madrid)
🏢 Sanofi
📍 Madrid