Submission Manager – France

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.

Here’s what makes us unique—

We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.

Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Lead the dossier preparation and compilation, coordinate and manage the interaction with the different stakeholders.
• Member of the Global regulatory Team, coordinating all activities relating to management of submission
• Support GRL while building submission plan and annual regulatory roadmap. Responsible for generating and follow-up of the timetables. Provide dashboard for steering the regulatory activity to the GRL and Global Regulatory Team
• Responsible for the coordination of pre-submission activities (CTA, IND dossiers)
• Responsible for the coordination of initial submissions (M1 to M5) in EU and US
• Responsible for compiling the reference dossier (M2 to M5) in close collaboration with the GRL and
• Regulatory CMC: producing e-CTD backbone structure of the reference dossier, and identifying owners and timing for each deliverable