Labelling Specialist - Medical Evaluation (m/f)

REFERENZNUMMER:

291767/8

IHRE AUFGABEN:

-Create and maintain global regulatory product information (Reference Product Information, RPI) documents as the basis for worldwide harmonized labelling
-Work with the CCDS - compare the European requirements on the basis of the package leaflet
-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
-Complete a medical evaluation of the variations and propose amendments

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, Drug safety manager