Regulatory Affairs Officer

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

We are looking for an experienced Regulatory Affairs Officer to provide temporary, part-time operational support for regulatory activities (BeLux).

The consultant will support the local Regulatory Affairs team with regulatory submissions, marketing authorisation lifecycle management, labelling activities, and regulatory compliance for pharmaceutical products and medical devices.

Key Responsibilities:

• Prepare, submit, and track marketing authorization applications, variations, and renewals.
• Manage product registrations and lifecycle activities within Vault RIM.
• Maintain regulatory databases, including XEVMPD updates, ensuring data accuracy and compliance.
• Coordinate, maintain, and archive regulatory documentation.
• Ensure compliance with local regulatory requirements and submission timelines.
• Coordinate and review regulatory labelling documents (SmPCs, package leaflets, and product labels) and manage translations in Dutch, French, and German.
• Support labelling change requests, artwork reviews, approvals, and submission mock-ups.
• Support clinical trial labelling activities, including review of labels, Directions for Use (DFUs), and translated materials.
• Provide regulatory support for medical devices, including product registrations, documentation maintenance, IFU translations, and labelling compliance.
• Contribute to Compassionate Use and Medical Need Programs, regulatory intelligence activities, and quality/compliance support.

Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, or a related field.
• Previous Regulatory Affairs experience within the pharmaceutical industry.
• Good knowledge of Belgian and Luxembourg regulatory requirements.
• Hands-on experience with regulatory submissions, marketing authorization lifecycle management, and/or labelling activities.
• Ability to work autonomously and provide operational support with minimal onboarding.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Experience with regulatory tools such as Vault RIM, XEVMPD, LIFT, and/or TVT is a strong asset.
• Knowledge of medical device regulations and clinical trial labelling is desirable.
• Experience with Compassionate Use and Medical Need Programs is a plus.
• Fluency in English and preferably French and/or Dutch; German is considered an advantage.

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.