Executive - Regulatory Affairs

Roles & Responsibilities:
• Compile and prepare EU dossiers, focusing on Modules 1, 2, and 3
• Handle EU regulatory procedures including Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), and National procedures
• Manage national phase requirements for EU approvals
• Prepare, compile, and file post-approval variations to relevant EU agencies
• Support CTD/eCTD dossier compilation and related regulatory activities
• Ensure compliance with European Medicines Agency (EMA) standards and national competent authorities

Qualification:
• M.Pharm or M.Sc in relevant disciplines

Experience:
• 2–7 years in regulatory affairs, preferably with formulation regulatory exposure in solid oral dosage forms
• Strong knowledge of EU regulatory requirements and procedures

Skills:
• Expertise in dossier compilation and submission processes
• Familiarity with EU regulatory procedures (DCP, MRP, National Phase)
• Knowledge of eCTD submission processes
• Strong attention to detail and documentation skills
• Good communication and coordination abilities

About the Organization:
Torrent Pharmaceuticals Limited is a leading Indian pharmaceutical company recognized for its global presence, innovation in healthcare solutions, and commitment to regulatory excellence in drug development and submissions.