Global Labeling Manager (m/w) - befristet
Aktuell unterstützen wir einen unserer Kunden bei der Suche nach einem Global Labeling Manager (m/w).
Ideal auch für (Quer-)Einsteiger in den Bereich Regulatory Affairs!
Aufgaben:
- Update core texts SmPCs/PL/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals. Coordinate translations for CPs.
- Define submission strategy for EU and interact with HA as needed.
- Ensure in-time hand-over of variation package or response documents to submission teams.
- Interact with country organizations, medical departments and pharmacovigilance to ensure timely submission of labelling changes.
- Maintain databases and sharepoints as defined.
- Coordinate labelling projects or specific safety tasks as assigned.
- Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.
- Represent Global Labelling team in inspections and audits.
- Technical and administrative support to Senior Global Labelling Managers and Head of Global Labelling.
- Mentor less experienced team members.
Voraussetzungen:
- Erfahrung im Bereich DRA / EU (2-3 Jahre)
- Erfahrung Labeling
- Erfahrung in der pharm. Industrie
- erfolgreiches Studium naturwissenschaftlicher Bereich
zur Vakanz
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