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 deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. 

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 global/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 pioneering biopharma company 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. 

#LI-EUR

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

The salary range for this position is :€48 000,00 - €64 000

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.