JOB DESCRIPTION

Position: Senior Manager / Manager EU CMC, TT & Site Transfer

Department: Drug Regulatory Affairs

Reporting to: Head Regulatory Affairs / DRA Head
Job Location: Gurugram

Main Objective:

To manage regulatory activities for European markets, especially EU/EEA dossier preparation, CMC documentation, technology transfer, manufacturing site transfer, variation filing, and regulatory support to R&D;, QA, QC, Production and Validation teams.

Key Responsibilities:
Prepare, review and compile EU CTD/eCTD dossiers, mainly Module 1, Module 2.3 and Module 3.
Handle CMC documentation for tablets, capsules, and injectable products, as applicable.
Review and coordinate documents required for technology transfer from R&D;/sending site to manufacturing site.
Support site transfer activities, including change control, regulatory gap assessment, dossier impact assessment and variation strategy.
Identify whether manufacturing site changes, batch size changes, equipment changes, process changes or analytical method changes require Type IA,



Type IB or Type II variation.
Prepare regulatory variation packages for Europe, including present/proposed tables, justification, updated Module 3 sections, validation data, stability data and GMP documents.

Coordinate with QA, QC, Production, Validation and R&D; for documents such as:
Process validation protocol/report
Cleaning validation protocol/report
Analytical method transfer/validation
Stability protocol and data
Batch manufacturing records
Finished product specifications
API documents, CEP/ASMF/DMF support
GMP certificate and manufacturing authorisation
QP declaration, where applicable
Review TT documents from a regulatory point of view and ensure that the transferred process matches the approved dossier.
Check whether any site-transfer change can be implemented immediately or only after regulatory approval.
Coordinate with European consultants, MAH, agents, customers and regulatory autho

📌 Senior Manager Gurugram
🏢 Evolet Healthcare
📍 Gurugram