Job highlights
. Well verse with all India FDA portals . Co-ordinating with Plant QA for documentation required for Preparation,review and submission of various CTD and ACTD dossier as per ICH Guidelines for ROW markets
Product Permission and COPP application with FDA India.
Well verse with all India FDA portals
Co-ordinating with Plant QA for documentation required for Preparation, review and submission of various CTD and ACTD dossier as per ICH Guidelines for ROW markets.
Co-ordination with Quality Assurance, Quality Control, R&D;, Packing, Production for technical documents and samples.
Review and maintain regulatory documentation in databases or systems.
Reviewing of technical documents like BMR, BPR, DMF, Pharmaceutical Development Report, Process Validations, Method Validation, Stability Data, RM and finished products/packaging COA/specifications and Method of analysis for registration purpose.