Description
We are looking for a
Interim Labelling Manager (m/f)
Reference: -en
Start: 08/16
Duration: 5 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- 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 advise 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
- Be aware of local and regional labelling requirements, particularly in the EU
- Provide revised SmPC, labelling and PL texts in English for EU procedures (CP, MRP, DCP)
- Coordinate translations for CPs
Your qualifications
- Solid knowledge on Pharmacovigilance requirements
- Fluent language skills in English and German
- Profound experience with label requirements
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager