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.