Affaires Reglementaires jobs in France

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 offers an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. 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

• Consolidate clinical & non-clinical demand reports (API, DP, IMP).
• Generate IP/DP/DS Allocation reports & associated documentation monthly and upon changes.
• Plan and track product delivery with associated ERP tasks and documentation.
• Contribute to the Regulatory alignment report monthly and as needed.
• Submit DP Bulk Manufacturing Order requests.
• Update Marketed Product Needs in Compass.
• Prepare PAI reports.
• Analyze processes for optimization and improvement.

Requirements

About You

At Excelya, taking audacious steps is encouraged, so we're looking for individuals who are ready to grow with us and share our values.

• Experience: Proven ability to thrive in collaborative, fast-moving environments (talent matters most to us, so minimum years are not required!)
• Skills: Supply & clinical knowledge
• Education: Master's degree in the clinical or supply field
• Languages: French and good skills in English

Benefits

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 with 900 Excelyates, aiming to become Europe's leading mid-size CRO with the best employee experience.
• Our one-stop provider service model offers full-service, functional service provider, and consulting options, enabling 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 talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.