Regulatory Affairs Specialist
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Regulatory Affairs Professional (BeNeLux) | Hybrid
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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. xlxgzvr
- 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.
