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 Safety. 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.
- Develop and implement the regional regulatory strategy related to pharmacovigilance and drug safety.
- Oversee regulatory submissions and registrations with a focus on safety-related documentation and compliance.
- Act as the primary liaison with Local Regulatory Affairs (LRA) and Pharmacovigilance teams to ensure alignment on safety regulations.
- Consolidate and interpret regional safety requirements; advise the Global Regulatory Leader (GRL) on national safety regulations and changes.
- Support preparation and review of regulatory dossiers with an emphasis on safety data and risk management plans.
- Assist in drafting responses to Health Authorities’ questions concerning safety issues and provide detailed clarifications on regulatory queries.
- Maintain and update safety-related regulatory databases and documentation.
- Ensure Life Cycle Management (LCM) activities include safety-related variations and compliance updates.
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 (avoid requiring minimum years—talent matters most to us!)
- Skills: Solid understanding of registration file preparation, submission procedures, and Health Authority interactions.
- Education: Minimum Master’s degree (Bac +5) in compliance or a related field
- Languages: Fluency in French & 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 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.
