Regulatory Affairs Officer
Porto Salvo, Portugal Permanent Posted on Jan. 05, 2026Regulatory Affairs Officer
- Division / Business Unit: Regulatory Affairs
- Location: Lisbon
- Reporting to: Tomas Freitas
- Grade: L2
About the job
The Regulatory Affairs team, led by the Head of Regulatory Affairs, is dedicated to ensuring regulatory excellence and compliance across the full product lifecycle.
This includes the management of new Marketing Authorization Applications (MAAs), as well as all post-authorization activities such as variations, notifications, renewals, withdrawals, and transfers.
In addition to regulatory submissions, the team is responsible for the review and approval of artworks and promotional materials, ensuring alignment with local and international regulatory requirements.
We provide expert regulatory guidance to both internal and external stakeholders and maintain high-quality documentation within the Regulatory Affairs Quality System.
By actively contributing to both local and global projects, the team plays a key role in the continuous improvement of regulatory processes, reinforcing the company’s commitment to ethical standards, regulatory compliance, and patient safety.
About You
Education
· University degree in pharmacy, Life Sciences, or a related field.
Soft Skills
· Strong team spirit and ability to collaborate across departments
· Proactive and accountable mindset
· Analytical Thinking and problem-solving orientation
· Ability to manage priorities and respond to urgency
· Excellent organizational skills and attention to detail
· Quick Learner, able to grasp new concepts and frameworks
· High level of Integrity and professionalism
· Strong communication and diplomatic skills
· Openness to change and continuous improvement
· Results-driven approach
Technical Skills
- Solid knowledge of GxP - understanding of pharmaceutical Good Practices and regulatory and compliance requirements
- Experience in Regulatory Affairs
- Ability to interpret and apply regulatory guidelines and legislation
- Problem-solving capabilities – able to assess regulatory challenges and propose effective solutions
- Familiarity with regulatory platforms and document management systems
- Veeva Vault, Promomats
Language (oral and written)
· Portuguese (fluent)
· English (Fluent)
· Spanish (a plus)
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare,
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, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com
Pursue Progress. Discover Extraordinary.
Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
You have not viewed any jobs yet.
You have not saved any jobs yet.
Developing
our talent
We believe better is out there – and that extends to how we support people. Our People Strategy prioritizes inclusivity, transparency, and efficiency in talent development. It’s allowed us to chart personalized plans to keep employees and managers on the same page when it comes to training and succession planning. From upskilling to mentorship, we prepare our teams with the resources they need to pursue progress.
Find out more about this location
Experience possibility
-
Our culture & values
We're the first in Pharma to have a DE&I board. We also have Employee Resource Groups that create spaces for every Sanofian to be heard. Your voice matters – use it to shape our future.
-
Why Sanofi
Get access to the tools, training, and support to reach your goals. By fulfilling your potential, you’ll help us achieve our aim of halving the time from discovery to therapy.
-
Build a career with purpose
Bring your passion to your role and impact millions of people around the world. You're in the driver's seat – just set your goals, and we'll provide the training and support that will get you there.
Join our
talent community
What could we achieve together? Every Sanofian works on projects that truly make a difference to people’s lives.
Sign up today and discover our latest opportunities as soon as they’re available.