Senior Manager

Evolet Healthcare; Gurugram District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Evolet Healthcare in Gurugram seeks a Senior Manager/Manager EU CMC, TT & Site Transfer to lead regulatory activities for European markets. You will prepare EU CTD/eCTD dossiers, manage CMC documentation and oversee technology and site transfers across R&D, QA, QC, Production and Validation teams.

You will coordinate with European consultants, MAHs and authorities to ensure compliance with EU GMP and ICH guidelines and timely submissions for market authorisation renewals and variations.

Qualifications

• EU CTD/eCTD dossier structure.
• CMC regulatory requirements.
• Technology transfer and site transfer basics.
• Regulatory variation and dossier impact assessment.
• GMP expectations and CEP/DMF handling.
• QP declaration and batch release concepts.

Responsibilities

• Prepare, review and compile EU CTD/eCTD dossiers, mainly Module 1, 2.3 and 3.
• Handle CMC documentation for tabs, capsules, and injectables as applicable.
• Coordinate technology transfer documents from R&D/sending site to manufacturing site.
• Support site transfer activities including variation strategy and regulatory gaps.
• Identify variation types (Type IA/IB/II) for site and process changes.
• Prepare regulatory variation packages for Europe with updated modules and data.
• Coordinate QA, QC, Production, Validation and R&D documents for regulatory review.
• Respond to regulatory deficiencies related to CMC, validation, stability and packaging.

Skills

EU regulatory

CMC regulation

Dossier preparation

Regulatory query response

Cross-functional coordination

Job description

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.
• Fast and complete response to customer/authority queries.
• Proper tracking of country‑wise and product‑wise regulatory status.