Regulatory Affairs Manager

About the role

We are Kintiga, a pan‑European specialist supporting health‑technology developers to secure patient access across Europe. We are seeking a Regulatory Affairs Manager to lead BeNeLux regulatory and pharmacovigilance activities, based in Ghent with a one‑day‑per‑week office presence.

Key responsibilities

• Manage local (BeNeLux) regulatory activities to obtain marketing authorisations for pharmaceutical products.
• Lead or support Responsible for Information and Publicity (RIP) activities.
• Oversee local pharmacovigilance activities, including safety reporting and ICSR management as the local QPPV.
• Contribute to reimbursement dossiers through medical writing, budget impact analysis and real‑world evidence collection.
• Participate in Medical Affairs projects such as patient‑journey development, training slide decks and creation of patient, HCP and marketing materials.
• Coordinate stakeholder interactions, including advisory boards and scientific presentations.
• Handle medical information enquiries at local and global level and ensure appropriate reporting of adverse events, technical complaints or special situations.
• Manage field market‑access research activities.

Required profile

• Master’s or PhD degree in biomedical sciences, biotechnology, pharmaceutical sciences, drug development, medicine or related field.
• Fluency in Dutch, French and English (native Dutch or French preferred).
• Proven experience in a pharmaceutical company or a consulting/clinical services agency serving the pharma industry.
• In‑depth knowledge of local and EMA regulatory requirements.
• Familiarity with RIP activities, EU/Local GVP and QPPV responsibilities.

Required skills

• Regulatory affairs (EMA and local) expertise.
• Pharmacovigilance management (QPPV duties).
• Medical information handling and adverse‑event reporting.
• Budget impact analysis and real‑world evidence (RWE) collection.
• Medical writing for reimbursement and medical‑affairs deliverables.
• Stakeholder management, including advisory boards and scientific presentations.