Manager / Senior Manager / AGM- Regulatory Affairs -Europe

About the Role

We are seeking an experienced Regulatory Affairs professional to join our CMC (Chemistry, Manufacturing & Controls) team at our Chennai office, focused on dossier preparation and lifecycle management for pharmaceutical products across the European Union, United Kingdom, and Australian markets. This role is being hired at the Manager / Senior Manager / AGM level depending on the candidate's depth of experience and demonstrated ownership of regulatory strategy. The ideal candidate will bring deep, hands-on expertise in CMC regulatory strategy and a strong track record of successful submissions in these regions.

Key Responsibilities

• Prepare, review, and compile the CMC (Module 3) sections of regulatory dossiers in CTD/eCTD format for new marketing authorisation applications, variations, and renewals
• Develop and execute CMC regulatory strategies for submissions in the EU (CP/DCP/MRP procedures), UK (MHRA), and Australia (TGA)
• Coordinate with R&D, Quality Assurance, Manufacturing, and Analytical Development teams to gather and validate technical data for dossier compilation
• Manage post-approval variations (e.g., Type IA/IB/II in EU, UK variation classifications, TGA variations) related to manufacturing changes, specifications, stability, and API/vendor changes
• Respond to regulatory queries and deficiency letters from health authorities (EMA, MHRA, TGA) within required timelines
• Maintain up-to-date knowledge of evolving regulatory guidelines (ICH, EMA, MHRA, TGA) and ensure internal compliance
• For Senior Manager/AGM level: take ownership of a product portfolio, represent Regulatory Affairs in cross-functional leadership discussions, and mentor/guide junior regulatory affairs team members on CMC documentation practices