Job Description
The Regulatory Labeling Manager:
Drives and optimizes the strategy for the creation and maintenance of Core Data Sheet (CDS). Provide guidance and expertise to product teams on CDS supporting documents
Authors and maintains CDS, as well as manages the CDS processes in collaboration with regulatory product responsible and product team.
Drives and optimizes the strategy for the creation and maintenance of EU and US product information package. Authors and maintains these product information documents. Leads/contributes company responses to HA questions pertaining to EU and US labeling.
Provides regulatory strategic recommendations concerning acceptable labeling in regional markets, in collaboration with the relevant functions.
Guides and supports the implementation of CDS into the Local Product Labels and manages local label deviations.
Gives specific guidance on labelling regulatory issues such as legislation, guidelines, procedures to the RAFT and Project teams.
Leads or contributes to establishment or improvement of working processes and standards
Do you hold experience in CCDS/ CDS/ Cored Data Sheets?