Regulatory Affairs Officer
Posted: 2 days ago
Job Description
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 DoManage 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 YouTrilingual (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.
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