Regulatory Affairs Manager
il y a 2 semaines
Onze klant is 19de grootste farmaceutisch bedrijf in Europa gevestigd in Diegem en is op zoek naar een **REGULATORY AFFAIRS MANAGER**
Je bent verantwoordelijk voor alle regulatory activiteiten binnen de organisatie en rapporteert rechtstreeks aan de Country Manager
**Verantwoordelijkheden**
- Verkrijgen en behouden van marketingvergunningen in de Benelux.
- Op de markt brengen van producten met een correcte inhoud van de verpakkingscomponenten.
- Opvolging van prijs
- en terugbetalingsdossiers.
- Qualified Person voor batch release.
- Verantwoordelijk voor administratieve controle van producten uit EU en beheer van kwaliteitsklachten en gerelateerde aspecten (SOP en wetgeving).
- Back-up voor Medical Director als contactpersoon voor Pharmacovigilance.
- Ondersteuning van de Medische en Marketingafdelingen.
- Coaching van de Regulatory Affairs Officer en Management Assistant.
- Masterdiploma farmacie of gelijkwaardig.
- Meerdere jaren ervaring in regulatory affairs is verplicht.
- Kennis van regelgeving voor farmaceutische producten
- Je hebt een goed begrip van gezondheidseconomie, gezondheidsresultaten en het vermogen om te articuleren met betrekking tot deze onderwerpen.
- Het vermogen om samen te werken met belangrijke functies (Commercie, Controlling,...).
- Nauwkeurig en efficiënt
- Flexibel, dynamisch, georganiseerd, teamspeler
- Vaardig in Nederlands, Frans en Engels
- Aantrekkelijk salaris en voordeelpakketten
- Hospitalisatie en groepsverzekering
- Thuiswerken
- Bonusplan
- Maaltijdcheques en eco-chèques
- Mobiliteitsplan
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