Regulatory Affairs & Labelling Associate (Dutch/English/French)

About the role

The Regulatory Affairs & Labelling Associate ensures that local prescribing information aligns with the CCDS and EU labelling, meeting regulatory expectations and supporting product availability. The role works in a hybrid setting, combining on‑site collaboration in Wavre with remote work.

Key responsibilities

• Act as Variations Officer and Label Officer, overseeing label changes and variations.
• Serve as the local expert for Regulatory Data Management Systems, ensuring high‑quality data entry.
• Update electronic systems with new safety, indication, or efficacy information.
• Assess documentation, propose submission strategies, and submit changes to regulatory authorities.
• Coordinate label development, approval, and implementation after regulatory approval.
• Maintain oversight of all labelling activities and communicate potential issues to senior management.
• Collaborate with supply chain to anticipate product back‑orders.
• Assist in developing regulatory SOPs and lead meetings with Western European regulatory groups.
• Review promotional materials for compliance with approved labelling and pricing.

Required profile

• Bachelor’s degree in Administration with regulatory experience, or Master’s in Life Sciences with relevant internship/experience.
• Fluency in English and Dutch or French, with good understanding of the other language.
• Strong coordination, organizational, and initiative‑driven mindset.
• Ability to manage multiple tasks, set priorities, and work accurately and efficiently.
• Right to work in Europe.

Required skills

• Microsoft Word
• Microsoft Excel
• Adobe Acrobat
• Regulatory Data Management Systems

What we offer

• Hybrid working model (3 days onsite in Wavre, 2 days remote).
• Full‑time permanent position.