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Associate Regulatory Site Officer

Il y a 3 mois

Antwerpen, Flandre, Belgique Maandag Temps plein
**Over de functie**:
Als **Associate Regulatory Site Officer** zal je ondersteuning bieden bij de regulatory CMC-dossierbeheersactiviteiten voor verschillende farmaceutische producten. Je bent verantwoordelijk voor het beheren en beoordelen van CMC (Chemistry, Manufacturing and Controls) dossiers, variaties, verlengingen, jaarlijkse rapporten, site-registraties en territoriale uitbreidingen als onderdeel van de verantwoordelijkheid voor het beheer van de regulatory Life-cycle van producten. Dit houdt ook in het implementeren van wijzigingsbeheerupdates van onze partnersites in de bestaande regelgevende dossiers en het voorbereiden van bijbehorende regelgevende CMC-documentatie voor indiening bij de autoriteiten, in samenwerking met interne experts en externe partners.

Verder zal je impact van voorgestelde wijzigingen op de bestaande regelgevende submissions analyseren, en operationele documentatie/rapporten beoordelen om te zorgen voor naleving van de dossiers.

**Functie eisen**:
Als **Associate Regulatory Site Officer **ben/heb je:

- Een Bachelor of Master in een wetenschappelijke richting
- Ervaring met CMC en een achtergrond in het regulatory verhaal (kennis van Veeva Vault RIM is verwacht)
- Ervaring met major market submissions zoals US, EU Japan, China,...
- Sterke organisatorische skills en een oog voor details
- Sterke communicatieve vaardigheden in de Engelse en Nederlandse taal

**Over het bedrijf**:
Je komt als **Associate Regulatory Site Officer** 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 of freelance overeenkomst
- 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.

Bachelor,Master / PHD
4-6 jaar,6-9 jaar