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

About the role

We are looking for a Regulatory Affairs & Labelling Associate who will ensure that local prescribing information aligns with the CCDS and EU labelling. The role combines variation management, label development and coordination with internal and external stakeholders, working on‑site three days a week in Wavre and remotely two days.

Key responsibilities

• Act as Variations Officer and Label Officer, managing label changes from data receipt to regulatory submission.
• Maintain and operate the company’s Regulatory Data Management Systems and related electronic tools.
• Assess documentation, propose submission strategies, and submit variations to authorities according to internal procedures.
• Coordinate label development, approval and implementation with label centres and electronic systems.
• Communicate proactively with Head of Regulatory Affairs, QA Manager and Supply Chain to anticipate issues and back‑orders.
• Support the creation and update of RA SOPs and ensure compliance of promotional material with approved labeling.
• Lead meetings with Western European and corporate regulatory groups on labeling matters.

Required profile

• Bachelor’s degree in Administration or equivalent with regulatory experience in the pharmaceutical industry, or a Master’s in Life Sciences with relevant internship/experience.
• Fluent in English and Dutch (or French) with a good understanding of the other language.
• Strong coordination, organizational and prioritisation skills; ability to work accurately and efficiently.
• Right to work in Europe.

Required skills

• MS Word
• MS Excel
• Acrobat
• Regulatory Data Management Systems (electronic submission tools)

What we offer

• Full‑time permanent contract.
• Hybrid working model – 3 days onsite in Wavre, 2 days remote.