Regulatory Affairs Specialist

Fixed-term , Full time
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.
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.




Ensure compliance with local and EU regulatory requirements throughout the product lifecycle
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.
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
Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related Life Sciences field
Established experience in Regulatory Affairs within the pharm

📌 Regulatory Specialist and Senior Specialist (España)
🏢 Sanofi
📍 España