Beschreibung
Wir suchen für ein global agierendes, deutsches Pharmazieunternehmen einen Interim Labeling Manager im Frankfurter Raum.Interim Labeling Manager
* Creates and maintain Global Regulatory Product Information (Reference Product Information, RPI) documents as the basis for worldwide harmonized Labeling
* Leads all labeling-related activities within the cross functional product teams (e.g. Regulatory Sub-Team, Labeling Team, Global Project Team) for assigned products
* Ensures consistency between the RPI and national labeling documents and provide labeling related advise to the cross functional experts and to countries
* Coordinates and prepares response to labeling-related questions from authorities (content and format)
* Oversees creation and maintenance of minimum text requirements for global Master Packaging as the basis for worldwide harmonized packaging material
* Analyses competitor labeling
* Be aware of local and regional labeling requirements, particularly EU
* Provides revised SmPC, labelling and PL texts in English for EU procedures ( CP, MRP, DCP)
* Coordinate translations for CPs
* Have a solid knowledge on Pharmacovigilance requirements
Benötigte Kenntnisse
Industry specific skills
Pharma +++ > 5 yrs.
Languages
English +++ business fluent
French or Spanish 0 nice to have
German +++ business fluent
Non-IT skills
Global Regulatory Product Information +++ (excellent), > 6 yrs.
Label Requirements +++ (excellent), > 6 yrs.
Reference Product Information +++ (excellent), > 6 yrs.
Dauer: 1 Jahr und 6 Monate
Kapazität: Vollzeit 5 Tage die Woche (80 % vor Ort/ 20 % home based)
Mehr Informationen über Real Staffing erhalten Sie unter www.realstaffing.com/de