Executive- DRA

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.

1. 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.

1. Renewals

• Preparation and submission of renewal dossiers within regulatory timelines.
• Coordination for updated documents required for renewals.
• Tracking renewal status and maintaining regulatory database.

1. 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 / / (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.