Executive- DRA
PuneFull-time2–5 yrs4 L–₹4.8 L a yearPosted 3 months ago
Mid-level legal role at Sava Healthcare in Pune. Needs 2+ years and a B.Sc, M.Sc or B.Pharm. Pays ₹4–4.8 LPA.
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
- Compliance
- Regulatory affairs
- Documentation
- SOP writing