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 Data Management. 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 Mission

Manage and ensure the quality, consistency, and availability of regulatory data within RIMs (Regulatory Information Management systems) to support product registration, maintenance, and compliance activities worldwide.

Main Activities

• Enter, validate, and maintain regulatory data in RIM systems.
• Check the consistency and completeness of information from regulatory dossiers.
• Track the status of registrations and authorizations with health authorities.
• Prepare and provide regulatory exports or reports for inspections or audits.
• Collaborate with local and global Regulatory Affairs teams to ensure updates to information.
• Participate in migration or improvement activities for regulatory systems.
• Apply current standards and SOPs to ensure compliance (GxP, ALCOA).
• Complete and validated regulatory data in RIM systems.
• Regulatory reports meeting deadlines and requirements.
• Documentation of checks and validations performed.
• Contribution to migration/improvement plans for systems.

Requirements

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: 3+ years of experience in regulatory data management or Regulatory Affairs.
• Skills: Understanding of MA registration and maintenance processes, management of regulatory databases, data quality.

Tools: Veeva Vault RIM, PLR, IDMP, advanced Excel.
• Education: Master's degree in life and/or health sciences.
• Languages: Fluency in English language. Knowledge of French language is a plus.

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.

Excelling with Care

At Excelya, Care lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose.

Your challenges become our shared mission. Together, we transform bold ideas into reality-the Excelya way.

Apply today, become an Excelyate!