Role overview
Job description
Job Purpose 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. Key Responsibilities 1. 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. Handling deficiency queries and preparing responses within stipulated timelines. 2. Variation Management Preparation and submission of variation dossiers (Type IA, IB, Type II as applicable). Tracking variation approvals and implementati
…About this listing
- Source: SAVA HEALTHCARE's official careers site (via Keka) · last confirmed on the source 27 Oct 2026
- Posted 15 Jul 2026
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What they are looking for
Skills & requirements
Qualification
Educational Qualification B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences) Experience 2–5 years of experience in Regulatory Affairs
Department · Drug Regulatory Affairs
Hiring company
SAVA HEALTHCARE
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