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Regulatory Affairs Specialist

vor 3 Monaten


Frankfurt am Main, Hessen, Deutschland Merz Therapeutics GmbH Vollzeit

Position: (Junior) Specialist Regulatory Affairs (m/w/d)

In dieser Rolle sind Sie verantwortlich für die Aktualisierung und Pflege von regulatorischen Dokumenten. Sie sorgen dafür, dass alle Daten korrekt im Regulatory Information Management System (RIMS) eingegeben werden.

Zusätzlich verwalten Sie die Zugriffsrechte für RIMS sowie die EMA-Portale. Ihre Aufgaben umfassen auch die Einreichungen über xEVMPD/IDMP, die gemäß den behördlichen Vorgaben erfolgen müssen.

Diese Position erfordert ein hohes Maß an Detailgenauigkeit und Organisationstalent, um die Einhaltung der Vorschriften sicherzustellen.

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