Regulatory Affairs Professional

il y a 1 semaine


Mechelen, Belgique Brunel Temps plein

**First things first**: Wat mag je verwachten binnen jouw takenpakket? Jij zal ervoor zorgen dat farmaceutische en medische producten voorzien zijn van de juiste, juridische licenties. Je hanteert een adviserende en coördinerende rol in verband met de goedkeuring en registratie van geneesmiddelen. Op de hoogte blijven van de nationale en internationale wetgevingen en richtlijnen is een belangrijk deel van jouw functie. Jij zorgt ervoor dat de producten van het bedrijf voldoen aan deze regels. Je zal steeds goede argumenten opstellen voor nieuwe productlicensies en zal wetenschappers en fabrikanten adviseren over wettelijke eisen. Wettelijke inspecties uitvoeren, onderzoeksresultaten interpreteren, contact onderhouden en presentaties geven voor regelgevende instanties, zijn ook onderdeel van jouw takenpakket. Ook de leidinggevende zal je regelmatig adviseren op het gebied van de kwaliteit en veiligheid van de producten. Je zal registratiedossiers conform de geldende richtlijnen gaan voorbereiden, opstellen, indienen (met eventuele samenwerking met externe partners) en opvolgen. De ontwikkelingen op gebied van de wettelijke regelgeving zal je ten allen tijde blijven opvolgen.

Academic Master



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