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 integral/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 im

📌 Regulatory Affairs Specialist (Comunidad de Madrid)
🏢 Sanofi
📍 Comunidad de Madrid