Regulatory Affairs Officer

Are you an experienced Regulatory Affairs professional looking to join a leading global pharmaceutical organization? We’re seeking a Regulatory Affairs Officer (RAO) to manage and maintain medicinal product registrations across Belgium and Luxembourg.

You’ll play a key role in ensuring that all products comply with European and national regulations, supporting market access, and contributing to safe, compliant product launches.

What You’ll Do

• Manage registrations of medicinal products via MRP, DCP, and national procedures, ensuring compliance and on-time delivery.
• Maintain regulatory dossiers, perform variations and five-year renewals.
• Prepare, review, and submit national documentation and respond to health authority queries.
• Coordinate with Market Access, QA, Supply Chain, Marketing, and Sales to ensure product information aligns with approved registrations.
• Handle packaging and labeling activities – including translations, artwork checks, and approvals.
• Support tenders and promotional material reviews (SmPC, PIL, labeling texts).
• Manage local regulatory activities such as RMPs, RMAs, and DHPC submissions to the BeLux health authorities.
• Contribute to or lead local RA projects and continuous improvement initiatives.

About You

• Trilingual (Dutch, French and English)
• Degree in Pharmacy (industrial pharmacist preferred) or Life Sciences.
• Around 3+ years of experience in Regulatory Affairs within the pharmaceutical industry.
• Strong understanding of European registration procedures (MRP, DCP, national).
• Excellent communication, organization, and cross-functional coordination skills.
• Fluent in English, with good command of Dutch and/or French preferred.