Regulatory Affairs Officer

Regulatory 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

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!