Regulatory Affairs Officer (Strombeek-Bever, Belgium)

About the role

We are looking for a Regulatory Affairs Officer to join the Pharmaceutical Affairs department of EG, a leading Belgian generic medicines manufacturer. The role will support the development, registration and lifecycle management of prescription and OTC products, ensuring compliance with European and Belgian regulations.

Key responsibilities

• Prepare and submit regulatory dossiers for new medicines, generics, nutraceuticals and medical devices.
• Maintain product registrations and manage variations, renewals and extensions.
• Monitor changes in EU and Belgian regulatory legislation and advise internal teams.
• Coordinate with authorities, external partners and internal departments such as Quality Assurance and Pharmacovigilance.
• Support the development of biosimilars and specialized prescription medicines.

Required profile

• University degree in pharmacy, chemistry, life sciences or related field.
• Experience in regulatory affairs within the pharmaceutical industry.
• Good knowledge of EU and Belgian pharmaceutical regulations.
• Strong analytical and communication skills.

Required skills

What we offer

• Full‑time permanent position in Strombeek‑Bever.
• Opportunity to work in a fast‑growing market leader.
• Collaborative culture focused on motivation, energy and passion.