Regulatory Affairs Officer

About the role

The Regulatory Affairs Officer will provide regulatory advice and support for AbbVie’s pharmaceutical and medical device portfolio in Belgium, Luxembourg and the Netherlands. This role ensures compliance with local and EU regulations throughout the product lifecycle, from development to market authorization.

Key responsibilities

• Review and approve promotional and non‑promotional materials in line with legislation, local procedures and codes of practice.
• Monitor and manage marketing authorization dossiers, coordinating with EU regulatory affairs and ensuring timely registration.
• Maintain product information, packaging, and labeling consistency with company policies and CCDS.
• Collaborate with marketing, medical, QA, and commercial teams on launch activities, early access programs, and promotional campaigns.
• Act as Variations Officer and manage carton & label operations.
• Oversee regulatory activities for medical devices and Annex XVI devices, ensuring alignment with the Medical Device Regulation.

Required profile

Required skills