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