Regulatory Affairs Officer

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 within Regulatory Affairs. You will play a key part in ensuring compliance, supporting regulatory strategies, and enabling the successful development and maintenance of innovative health products. You’ll evolve in a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

• Prepare, compile, and submit regulatory dossiers (initial submissions, variations, renewals, responses to authorities’ questions).
• Ensure compliance of documentation and activities with applicable regulations (EU, ICH, national authority guidelines).
• Support regulatory strategy throughout product lifecycle (development, registration, post‑approval).
• Interface with health authorities, ethics committees, and internal/external stakeholders.
• Track regulatory timelines, approvals, and commitments to ensure smooth project progression.
• Review and validate labeling, artwork, SmPC/PIL, and promotional materials as per regulatory standards.
• Participate in the preparation of audits and inspections related to regulatory aspects.
• Maintain accurate documentation and records in line with internal SOPs and regulatory requirements.
• Identify regulatory risks and propose solutions or mitigation strategies.

• Experience: Prior experience or solid knowledge in regulatory affairs within the pharmaceutical, biotech, or medical device sector is essential.

• Skills:

1. Understanding of regulatory frameworks and submission processes (EU, EMA, national agencies).
2. Familiarity with product lifecycle management (development → registration → post‑marketing).
3. Ability to interpret regulations and provide clear guidance to operational teams.

• Education: Bachelor's degree in life sciences, pharmacy, or a related scientific discipline (or equivalent qualification).
• Languages: Fluent in French and English (written and spoken).

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.