Executive- DRA

About the role

To support the Regulatory Affairs function by preparing, compiling, and submitting dossiers for ROW (Rest of World) and EU markets , handling variations, and managing renewals in compliance with applicable regulatory guidelines.

What you'll do

• Dossier Preparation (ROW & EU)
• Preparation and compilation of CTD/eCTD dossiers for ROW and EU markets
• Review and verification of technical documents (Module 1–5)
• Coordination with QA, QC, Production, R&D, and other departments for required documentation
• Ensuring submissions comply with guidelines of regulatory authorities such as European Medicines Agency and respective country regulations

What you need

• 2–5 yrs of experience
• Compliance
• Regulatory affairs
• Documentation
• SOP writing
• B.Sc or M.Sc or B.Pharm or M.Pharm

What you get

• ₹4 L–₹4.8 L a year