Shivanjali Kawalkar is a Clinical Quality Assurance Associate at Ocugen since October 2023, with a strong background in regulatory affairs. Previously, Shivanjali worked as a Regulatory Affairs Intern at Northeastern University, where market research and global regulatory submissions were streamlined for the US, EU, and Canada, and collaborated on developing an ISO 13485-compliant Quality Management System. Other experience includes a Regulatory Affairs Internship at MedSapient focusing on mHealth application standards and regulations, as well as an internship with the Government Sericulture Department that involved data collection and analysis related to sericulture practices. Shivanjali holds a Master of Science degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, a Post Graduate Diploma in Computer Applications from Christian Eminent College, and a Bachelor of Science in Biotechnology from Govt. Holkar Science College.