Regulatory Affairs Consultant

il y a 15 heures

Ghent, Belgique WhatJobs Temps plein

Als Regulatory Affairs Consultant maak je deel uit van een dynamisch team dat verantwoordelijk is voor het interpreteren en toepassen van nationale en internationale regelgeving binnen de farmaceutische productieomgeving. Je ondersteunt de registratie‑ en lifecycle‑activiteiten van toegewezen producten en werkt nauw samen met diverse afdelingen zoals productie, QA, QC‑labs, Supply Chain, R&D en globale Regulatory teams (o.a. GCMC). Jouw verantwoordelijkheden Voorbereiden, opstellen en indienen van registratiedossiers (o.a. CTD, BLA, NDA) voor nieuwe en bestaande producten. Informeren van interne stakeholders over relevante regelgeving en vereisten voor submissions. Opvolgen en beantwoorden van vragen van gezondheidsautoriteiten binnen afgesproken deadlines. Beoordelen van post‑approval changes op de productiesite en bepalen van de bijhorende regulatory variaties; opstellen van de impacted dossieronderdelen. Samenwerken met globale en lokale regulatory collega’s om potentiële issues te identificeren en op te lossen. Actief bijdragen aan de planning en optimalisatie van teamactiviteiten zodat deadlines en registraties niet in het gedrang komen. Aanleveren van data voor jaarlijkse product reviews en ondersteunen bij dataverificaties van registratiedossiers. Bachelor of Master in Life Sciences (bv. Chemie, Biochemie, Farmaceutische Technologie, Industriële Farmacie, Biomedische Wetenschappen, Bio‑ingenieur) of gelijkwaardig door ervaring. Ervaring in de farmaceutische sector, bij voorkeur binnen Regulatory Affairs of Quality (PhD kan gelijkwaardig zijn). Sterke organisatorische vaardigheden, oog voor detail en een gestructureerde manier van werken. Je werkt zelfstandig maar functioneert uitstekend in teamverband. Je volgt procedures nauwgezet en hebt een proactieve, flexibele en leergierige houding. Goede kennis van Microsoft Office. Vlotte communicatie in het Nederlands en Engels, zowel mondeling als schriftelijk. Wie zijn wij? Al 20 jaar is pi Life Sciences een wereldwijde integratiepartner van topkwaliteit voor toonaangevende bedrijven in de life sciences-sector. Wij leveren wereldwijd waarde aan onze klanten dankzij de expertise van onze ingenieurs. pi Life Sciences biedt unieke lokale kennis die leidt tot strategisch advies van hoge kwaliteit, terwijl Abylsen haar wereldwijde visie en onderscheidende aanpak verspreidt om samen te groeien en nieuwe horizonten te verkennen. #J-18808-Ljbffr

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