ACAcme Services
Regulatory Executive
Mumbai ₹2-5 LPA Posted 18 Jul 2025
FULL TIME
Control
Bpr
DMF
r&d
Pharmaceutical
+1 more
Job Description
- 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.