Description
We are looking for an
Interim Labelling Manager (m/f)
Reference: -en
Start: asap
Duration: 16 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 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
Your qualifications
- 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
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager