Regulatory Affairs Specialist – BeNeLux (Hybrid)

About the role

We are seeking an experienced Regulatory Affairs Specialist to support our growing team across the Benelux region. The role is hybrid, combining on‑site collaboration with remote work, and involves a broad range of regulatory, pharmacovigilance, medical information and market access activities.

Key responsibilities

• Manage local regulatory activities and marketing authorisation submissions for Belgium, the Netherlands and Luxembourg.
• Coordinate Responsible for Information and Publicity (RIP) activities.
• Lead local pharmacovigilance tasks, including Local QPPV responsibilities.
• Contribute to reimbursement dossiers, medical writing and Real‑World Evidence (RWE) projects.
• Support Medical Affairs initiatives, stakeholder interactions and medical information requests.

Required profile

• Master's or PhD in Pharmacy or Medicine.
• Minimum of 2 years experience in the pharmaceutical industry.
• Strong knowledge of local and EMA regulatory requirements.
• Fluency in Dutch or French and English.

Required skills

• Regulatory affairs expertise.
• Pharmacovigilance (Local QPPV) experience.
• Medical writing and RWE project experience.
• Knowledge of RIP activities and EU/local GVP (asset).