Regulatory Regional Leader
il y a 18 heures
HybridOperations, PV & SafetyFull time
Saclay, Île-de-France, France
OVERVIEW
Description
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 the regional regulatory strategy and oversee registration processes in alignment with global objectives.
Ensure that regulatory dossiers comply with all relevant regional regulatory requirements.
Serve as the main point of contact with Local Regulatory Affairs (LRA) teams.
Consolidate and validate regional requirements; advise the Global Regulatory Leader (GRL) on specific national regulations.
Support the preparation of registration files, procedures, and Life Cycle Management (LCM) activities together with the GRL and submission manager.
Assist in drafting clear and accurate responses to Health Authorities’ questions.
Provide detailed explanations and context regarding Health Authority queries or feedback.
Ensure that regulatory databases and tracking systems are updated and maintained accurately.
**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**: Experience in regulatory affairs (junior profile with European regulatory experience strongly preferred) (avoid requiring minimum years—talent matters most to us)
**Skills**: Familiarity with regional registration processes, dossier preparation, and interactions with Health Authorities.
**Education**: Minimum Master’s degree (Bac +5) in clinical research 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.
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