iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

As Clinical Trial Coordinator VIE within our Regulatory Affairs team, you will support the Global Regulatory Affairs (GRA) Clinical Trial Application (CTA) manager team, to follow up/monitoring of CTA operational planning activities, manage activities related to CTA documentation in close collaboration with the Clinical trial team, and the Regulatory team.

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.

Ready to get started?

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:

Follow up/monitoring of Clinical Trial Application (CTA) operational planning activities.
Manage activities related to CTA documentation in close collaboration with the Clinical trial team, and the Regulatory team (coordinate, follow, check availability of component and completeness of CTA dossier and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments, etc.).
Manage activities specifically related to the Clinical trials under the European Regulation and its operational processes in the Clinical Trial Information System (CTIS).
Prepare appropriate CTA documents in the Sanofi repository systems.
Activities related to Development Safety Update Report (DSUR) delivery.
Manage activities related to tools /Sanofi Regulatory document and registration tracking tools (Vault RIM).
Contribute to data quality control, and appropriate data remediation in Vault RIM.
Monitor Key Performance Indicators by running reports, collating data and report as per oversight and governance process.

About you

Experience:

First experience in Regulatory Affairs or other relevant experience.

Soft and Technical skills:

Good communication skills.
Good negotiation skills.
Ability to solve issue & pro-active behaviour.
Ability to work with multi-function teams.
Ability to manage multiple projects.

Education:

Master’s degree in Pharmacy / Science or other related degree.

Languages:

Fluent English (written and verbal).