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Labelling Manager (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Projektbeschreibung
272763/1
IHRE AUFGABEN:
-Create and maintain global regulatory product information (Reference Product Information, RPI) documents as the basis for worldwide harmonized labelling
-Lead all labelling-related activities within the cross-functional product teams (e.g. regulatory sub-team, labelling team, global project team) for assigned products
-Ensure consistency between the RPI and national labelling documents and provide labelling-related advice to the cross-functional experts and to countries
-Coordinate and prepare response to labelling-related questions from authorities (content and format)
-Oversee creation and maintenance of minimum text requirements for global Master Packaging as the basis for worldwide harmonized packaging material
-Analyse competitor labelling
-Provide revised SmPC, labelling and PL texts in English for EU procedures ( CP, MRP, DCP)
-Coordinate translations for CPs
IHRE QUALIFIKATIONEN:
-Experience within the pharma
industry -Solid knowledge on pharmacovigilance requirements
-Awareness of local and regional labelling requirements, particularly EU
-Fluent usage of business German and English
-Experience in global regulatory product information
-Experience in Reference Product Information
-Experience in label requirements
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
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Einsatzort:
Hesseneck, Deutschland
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Projektbeginn:
asap
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Projektdauer:
18 MM
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges