Sanofi B.V. Global Regulatory Affairs

Sanofi B.V. based in Amsterdam in the Netherlands, is the legal entity which holds several Marketing Authorisations of Sanofi products. This is one of the sites where, in addition to various functions to support the local Dutch affiliate, also a large part of Sanofi’s Global Regulatory Affairs department is located, including a considerable part of the unit responsible for products in the therapeutic areas of Rare Diseases and Rare Blood Disorders. The Global Regulatory Affairs department is responsible for the maintenance of these licenses and for providing regulatory strategic input into the global development of new medicinal products, from a global, a European and a United States viewpoint.

Job description:

Working within the Global Regulatory Affairs department of the Rare Diseases and Rare Blood Disorders unit of Sanofi, and in liaison with your tutor, you will be involved in regulatory activities for projects in this portfolio for marketed products and products in development worldwide.

As part of this role, you will

· Provide support to the Regulatory Strategist and Global Regulatory Lead in the coordination, preparation and submission of regulatory documentation for (for example) orphan drug designation applications, paediatric investigation plans, scientific advice requests (briefing documents), variation applications, responses to commitments and questions from health authorities, clinical trial applications etc.

· Participate in operational team meetings,

· Provide support to prepare for interactions with health authorities and review agency feedback, in collaboration with the Regulatory Strategist and the Global Regulatory Lead within Global Regulatory Affairs, covering the regions Europe and the USA,

· Help assess changes in the regulatory and legislative landscape,

· Ensure the maintenance and compliance of regulatory databases and tools.

Profile sought:

You are looking for a 6-month internship , starting between February and March 2026 , as part of a Bac plus 5 or 6 degree in Pharmacy or Regulatory Affairs at a Faculty of Pharmacy or University.

For this position, you will need initial experience or knowledge in Regulatory Affairs.

You have a good command of MS Office software .

Working in an international environment, you are able to converse easily in English with non-French speakers.

Autonomous and motivated, you have good interpersonal skills, and are a team player with the ability to adapt. For this position, your organizational skills, rigor and analytical mind will enable you to carry out your missions successfully.

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 !