Smita Ghodekar

Smita Ghodekar is an experienced regulatory affairs professional currently serving as a Senior Specialist in Regulatory Information Systems at Alexion Pharmaceuticals, Inc. since September 2023. Previously, Smita worked at Cognizant as a Senior Process Associate, focusing on the preparation and submission of various regulatory applications for EU and international markets. Smita's career includes a role as a Regulatory Data Specialist at Tata Consultancy Services Limited, overseeing marketing authorization applications and maintaining global CMC data. Early professional experience includes a position as a Quality Compliance Associate at Vitality Business Solutions, ensuring compliance with regulatory requirements. Smita holds a Master of Science in Medical Devices Regulatory Affairs from South East Technological University and a Master's degree in Pharmaceutical Quality Assurance from the University of Mumbai, along with other academic achievements in clinical research and pharmacy.