Consultant Regulatory Affairs
il y a 3 semaines
**Over de functie**:
In jouw functie als Consultant Regulatory Affairs ben je verantwoordelijk voor de productieregistratie activiteiten van jouw producten. Je beheert de voltooiing van je projecten, beheert je eigen tijd om afgesproken doelen te bereiken. Je werkt samen met interne afdelingen, R&D en wereldwijde collega's om de introductie van nieuwe producten te ondersteunen op de site. Hiervoor ondersteun je de reglementaire indieningen en stelt het dossier op met de wettelijke vereisten. Je staat in contact met je collega's zodat je tijdig weet in te spelen op mogelijke problemen. Wanneer de Gezondheidsraad verzoeken stuurt, reageer je tijdig en beoordeel je wijzigingen na goedkeuring. Verder werk je samen via het netwerk van andere belanghebbende om CMC-indiening van hoge kwaliteit te leveren.
**Functie eisen**:
Als Consultant Regulatory Affairs omschrijf je jezelf als dynamisch, zelfstandig, enthousiast en leergierig. Daarnaast heb/ben je als Consultant Regulatory Affairs:
- Master in Life Science (geneesmiddelenontwikkeling, biomedische wetenschappen, bio-ingenieur,..)
- Ervaring in regelgeving en kwaliteit binnen een GMP-omgeving
- Kennis van medicatieregelgeving en de regelgevende richtlijnen van EMA en FDA
- Goede vaardigheden in woord en geschrift (onderhandeling en beïnvloeding)
- Vloeiend in het Nederlands en het Engels
Een pluspunt is ervaring met CMC.
**Over het bedrijf**:
Je komt als Consultant Regulatory Affairs terecht bij Maandag®, een projectorganisatie binnen de technische sector. Wij verbinden jouw talenten en persoonlijkheid met technisch uitdagende projecten. Door een persoonlijk contact met onze opdrachtgevers, kunnen we er samen voor zorgen dat jouw potentieel ten volle benut wordt
Wat mag je verwachten?
- Een vast contract van onbepaalde duur
- Salaris of tarief naar jouw ervaring
- Hospitalisatieverzekering
- Groepsverzekering
- Maaltijdcheques van €8/gewerkte dag
- ECO-cheques van €250/jaar
- 20 dagen vakantie + 12 ADV dagen
- Toegang tot opleidingsmogelijkheden en een opleidingsplatform
**Solliciteer**:
Herken jij jezelf in dit profiel? En lijkt werken bij Maandag® je een mooie stap? Solliciteer dan meteen. Wie weet ziet jouw maandag er binnenkort dan net zo tof uit als die van ons.
Master / PHD
2-4 jaar,0-2 jaar
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