Opening in Regulatory Affairs- Europe Market @ Medreich – Bangalore
Responsible for planning the dossier submissions in MRP, DCP and CP procedures,
complete review of submission tasks and tracking the submission related issues.
Responsible for compiling the dossiers (in eCTD and NeeS) and coordinate these
compilation processes across multiple collaborations like Regional Dossier Strategists,
In-country Regulatory Liaisons, partner organizations etc
Compilation and review of Variation (Type I & Type II) packages for Europe Market.
Identifying the required changes in the documents for the respective variations, coordinating
for the updated documents and compiling the dossiers.