Regulatory Affairs Manager

About the role

Kintiga is seeking a Regulatory Affairs Manager to lead local regulatory activities across the BeNeLux region. The role combines regulatory management, pharmacovigilance, medical information, and support for market access and medical affairs projects within a fast‑growing health‑technology consultancy.

Key responsibilities

• Manage local (BeNeLux) regulatory submissions to obtain marketing authorisations for pharmaceutical products.
• Support or lead Responsible for Information and Publicity (RIP) activities.
• Oversee local pharmacovigilance duties as the local QPPV, including ICSR handling and safety reporting.
• Contribute to reimbursement dossiers through medical writing, budget impact analysis and real‑world evidence collection.
• Participate in medical affairs initiatives such as patient‑journey development, training decks and creation of HCP/marketing materials.
• Coordinate stakeholder interactions, advisory boards and scientific presentations.
• Handle medical information enquiries and report adverse events, technical complaints or special situations at both local and global levels.
• Conduct field market‑access research.

Required profile

• Master’s or PhD in a scientific discipline (e.g., biomedical sciences, biotechnology, pharmaceutical sciences, drug development, medicine).
• Proven experience in a pharmaceutical company or consulting agency serving the pharma sector.
• In‑depth knowledge of local and EMA regulatory requirements; experience with RIP activities is a plus.
• Familiarity with EU/Local Good Pharmacovigilance Practice (GVP) requirements.
• Fluency in Dutch, French and English (preference for Dutch or French).
• Strong interest in developing market‑access and medical‑affairs expertise.

Required skills

• Regulatory affairs expertise (local & EMA)
• Pharmacovigilance (QPPV responsibilities)
• Responsible for Information and Publicity (RIP) processes
• EU/Local Good Pharmacovigilance Practice (GVP)