Regulatory Affairs Specialist
About this opportunity
Job title: Regulatory Affairs Specialist (Fixed-term)
Location: Madrid
Job type: Fixed-term - 4 months, 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.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 305 comparable Regulatory Affairs roles across 66 biopharma companies.
Salary context
85 of 305 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 305 comparable roles
+ 31 more countries
Seniority mix
261 of 305 peers have a known seniority level
Therapeutic area mix
33 of 305 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.