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 implementation timelines.
Maintaining updated records of approved variations.
3. Renewals
Preparation and submission of renewal dossiers within regulatory timelines.
Coordination for updated documents required for renewals.
Tracking renewal status and maintaining regulatory database.
4. Regulatory Compliance & Documentation
Maintaining regulatory trackers and submission databases.
Ensuring document archival as per SOPs.
Supporting audits and inspections related to regulatory documentation.
Educational Qualification
B.Pharm / M.Pharm / B.Sc / M.Sc (Life Sciences)
Experience
2–5 years of experience in Regulatory Affairs.
Hands-on experience in ROW and EU dossier preparation.
Experience in handling variations and renewals.
Key Skills & Competencies
Strong knowledge of CTD/eCTD format.
Understanding of EU and ROW regulatory guidelines.
Good documentation and coordination skills.
Attention to detail and timeline management.
Proficiency in MS Office and regulatory software tools.
