Regulatory Affairs Specialist

Pharmeleon; Vlaanderen; Hybride; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Pharmeleon in Belgium is seeking an experienced Regulatory Affairs Professional to support BeNeLux regulatory activities, pharmacovigilance and medical affairs, in a hybrid setup.

You hold a Master’s or PhD in Pharmacy or Medicine, have 2+ years in pharma, fluency in Dutch or French and English, and strong EMA/regulatory knowledge; you will drive submissions, RIP activities and local reimbursement efforts.

Qualifications

• Master's or PhD in Pharmacy or Medicine.
• Minimum of 2 years of experience in the pharmaceutical industry.
• Strong knowledge of local and EMA regulatory requirements.
• Experience with RIP activities and/or EU/local GVP is an asset.
• Strong organisational and stakeholder management skills with an entrepreneurial mindset.
• Fluency in Dutch or French and English.

Responsabilités

• Manage BeNeLux regulatory activities and marketing authorisation submissions.
• Support and/or manage RIP activities.
• Coordinate local pharmacovigilance activities, including Local QPPV responsibilities.
• Contribute to reimbursement dossiers, medical writing and Real-World Evidence projects.
• Support Medical Affairs initiatives, stakeholder interactions and medical information activities.

Connaissances

Regulatory affairs

Pharmacovigilance coordination

Stakeholder management

Project coordination

Formation

Master's degree in Pharmacy or Medicine

Description du poste

Regulatory Affairs Professional (BeNeLux) | Hybrid

We are looking for an experienced Regulatory Affairs Professional to join a growing team. In this diverse role, you will support regulatory activities across the BeNeLux while contributing to Pharmacovigilance (Local QPPV), Medical Information, Market Access and Medical Affairs projects.

Your responsibilities

• Manage local (BeNeLux) regulatory activities and marketing authorisation submissions.
• Support and/or manage Responsible for Information and Publicity (RIP) activities.
• Coordinate local pharmacovigilance activities, 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 activities.

What we're looking for

• Master's or PhD in Pharmacy or Medicine.
• Minimum of 2 years of Experience in the pharmaceutical industry.
• Strong knowledge of local and EMA regulatory requirements.
• Experience with RIP activities and/or EU/local GVP is an asset.
• Strong organisational and stakeholder management skills with an entrepreneurial mindset.
• Fluency in Dutch or French and English

An excellent opportunity for an experienced Regulatory Affairs Officer ready to take the next step in their career.