Summary The Senior Regulatory Coordinator Sr RC works under close supervision to support for development including line extension and maintenance projects through development registration and approval including post approval commitments To maximize operational effectiveness Collaborate with RA GDD Development Units RA GDD CMC Regional Representatives MoW LACan EU China Japan Novartis Technical Operations NTO and Quality Assurance to align on planning execution communication and completion of assigned projects Key Responsibilities Ensure procurement of various key regulatory components e g ordering certificates GMP registration samples COA s and other regulatory documents as per the needed to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders NTO Reg CMC Global labelling RA Ops for renewals SCM Tech Ops for Regulatory samples HA such as USFDA Swiss medic EMA Consular Services for certificates etc External Service providers Support for planning and management of timely delivery of critical regulatory materials registration samples and various regulatory authorized documents certificates for product license renewals manufacturing site transfers current registration submissions word wide as per health authority requirements For new submissions - Represents Regulatory Affairs LCM BOE team in in NTO project team meetings RA global and regional team meetings Organize regulatory readiness with relevant line functions and with Country Organizations Regions for timely delivery of submission and approvals Track progress of assigned projects including timelines and dossier deliveries Ensure quality and compliance with global regulatory requirements countries requirements and adherence to regulatory internal policies and processes Support for maintaining country requirement lists and conducting need-based surveys interaction with country organizations Contribute to non-project related initiatives and excellen

📌 Sr Regulatory Coordinator (Hyderabad)
🏢 Novartis
📍 Hyderabad