Regulatory Affairs Executive

We’re hiring API - Regulatory Affairs professionals ! Join us to drive global DMF submissions, regulatory compliance, and strategic market access. Apply now and grow with a high-impact team. We are seeking a dynamic and detail-oriented professional to manage end-to-end regulatory submissions and lifecycle activities for API dossiers across global markets. The role plays a critical part in ensuring timely approvals, regulatory compliance, and seamless coordination across functions. Regulatory Submissions & DMF Management : Prepare, review, and submit Drug Master Files (DMFs) in compliance with global regulatory requirements and Manage full DMF lifecycle including amendments, annual updates, and variations Ensure timely submission of regulatory dossiers and responses to health authorities Maintain accurate tracking and documentation of DMFs, LOAs, and deficiency responses Technical Evaluation & Documentation : Evaluate route of synthesis, impurity profiling, and control strategies Revie...