Interim Labelling Manager (m/f)

REFERENZNUMMER:

279648/1

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 the cross-functional experts and countries with labelling-related advice
-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 of pharmacovigilance requirements
-Awareness of local and regional labelling requirements, particularly in the 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