Regulatory Affairs Officer
On-site · Zaventem, Flanders, Belgium
Job Summary
Regulatory Affairs Officer responsible for submitting Marketing Authorization Applications and variations to the FAMHP, MEB, and the Ministry of Luxembourg, and for updating SmPCs and labeling in the Benelux. The role includes coordinating sponsorship and promotional material approvals under supervision, ensuring MDR compliance for medical devices, collaborating within European procedures (DCP/MRP), providing updated SmPCs to sales teams, and preparing files related to promotional transfer of value. The position requires gathering quality documentation from new medical devices, contributing to supplier assessments, and monitoring sponsorship and promotional material in the Benelux. Candidates should have 3-5 years of regulatory affairs experience in a pharmaceutical environment, strong communication skills, accuracy, planning abilities, stress resistance, and an open, pragmatic, multilingual mindset (French, Dutch, English).
Required Qualifications
- 3-5 years professional experience in regulatory affairs in a pharmaceutical environment
- Team player, stress resistant, and steadfast
- Good communication and social skills
- Accuracy and structuring qualities
- Acts according to plan and sets priorities, makes efficient use of methods, systems and resources
- Analytical, helicopter view, flexible
- Open personality, pragmatic French, Dutch and English speaking
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.