Bewerbende mit Behinderungen erwünscht 👨‍🦽👨‍🦯🦻 Global Regulatory Affairs Clinical Trials Coordinator - VIE Contract

Global Regulatory Affairs Clinical Trials Coordinator - VIE Contract

• Location: Germany, Berlin
• Target start date: 01/11/2025

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 Global Regulatory Affairs Clinical Trials Coordinator VIE within our Global Regulatory Affairs team, you'll manage regulatory activities related to Clinical Trials Applications, from planning and dossier preparation, then submission, responses to Health Authorities and approvals of Trials. We are developing our knowledge in Clinical Trial Applications (CTA) related Intelligence, in particular our knowledge in the European Clinical Trial Regulation. Your work will support knowledge development, and field experience for the European Clinical Trial Regulation processes.

Ready to get started?

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:

• Provide regulatory expertise to Sanofi key stakeholders and help teams understand and follow important healthcare regulations.
• Set up processes and coordinate the preparation of Clinical Trial Applications (CTAs).
• Work closely with different departments including R&D, Clinical Operations, and Pharmacovigilance teams.
• Ensure all documentation meets quality standards.
• Monitor the progress of CTAs through submission and approval stages.
• Identify potential issues early and develop practical solutions, keep projects moving forward on schedule and drive process improvement.
• Help implement new regulatory processes (eg. Clinical Trial Regulation in Europe, EU Clinical Data Disclosure).
• Contribute to developing more efficient ways of working, stay current with changing regulations and help teams adapt.

About you

Experience:

• Previous experience in pharmaceutical industry in Regulatory Affairs or similar field.
• Clinical Trial Regulations experience is highly preferred.

Soft and technical skills:

• Good communication & negotiation skills.
• Proactiveness, and problem-solving ability.
• Ability to work with cross-functional teams.
• Ability to handle multiple tasks and projects simultaneously.

Education:

• Master's Degree in Pharmacy, or other relevant scientific field.

Languages:

• Fluency in English, German knowledge would only be an asset, but is not needed for the job.

Why choose us?

• Be part of a pioneering biopharma company where patient insights shape drug development.
• Work at the forefront of AI-powered science that accelerates discovery and improves outcomes.
• Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams.
• 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.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.

iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow.

Sanofi's Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work.

#LI-EUR

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.