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 authorities for query response.
- Prepare responses to regulatory deficiencies related to CMC, manufacturing process, validation, stability, specifications, impurities, nitrosamine risk, elemental impurity risk and packaging.
- Maintain regulatory lifecycle tracking for each product and country.
- Ensure all regulatory submissions are aligned with EU GMP, ICH guidelines and approved marketing authorisation requirements.
- Support product selection for Europe by checking regulatory feasibility, BE requirement, RLD/reference product, dossier gap and site readiness.

Required Knowledge:

- EU CTD/eCTD dossier structure
- EU variation classification
- CMC regulatory requirements
- Technology transfer and site transfer
- Process validation and cleaning validation basics
- Analytical method transfer
- Stability requirements
- EU GMP expectations
- CEP, ASMF/DMF handling
- QP declaration and batch release site concept
- MAH/customer communication
- Regulatory query response preparation

Preferred Experience:

- 10-15 years Experienced Candidate,
- Experience in Europe-regulated dossiers
- Experience in manufacturing site addition or site transfer
- Experience with oral solid dosage forms; injectable experience is an advantage
- Worked with EU customer, consultant, MAH or CDMO project

Key KPIs:

- Timely preparation of complete dossier/variation packages.
- Minimum regulatory deficiencies due to CMC documentation gaps.
- On-time support for TT and site-transfer projects.
- Accurate regulatory impact assessment before any manufacturing change.
- Rapid and complete response to customer/authority queries.
- Proper tracking of country-wise and product-wise regulatory status.

📌 Senior Manager (Gurugram)
🏢 Evolet Healthcare
📍 Gurugram