Amita Gavaskar
About Amita Gavaskar
Amita Gavaskar is a Manager of Global Regulatory Affairs with over 12 years of experience in the field. She has held various positions at notable companies, including PTC Therapeutics, Sun Pharmaceutical Industries, and Sandoz, specializing in regulatory affairs and CMC strategy management.
Current Role at Adaptimmune
Amita Gavaskar serves as the Manager of Global Regulatory Affairs at Adaptimmune, a position she has held since 2022 in Philadelphia, Pennsylvania. In this role, she is responsible for overseeing regulatory strategies and ensuring compliance with global regulatory requirements. Her work involves managing the preparation and submission of regulatory filings, as well as compiling stability data and summary reports to support product development and approval processes.
Previous Experience in Regulatory Affairs
Before joining Adaptimmune, Amita Gavaskar held various positions in regulatory affairs across multiple organizations. She worked as a Senior Manager of Global Regulatory Affairs at PTC Therapeutics, Inc. for 11 months in New Jersey. Additionally, she spent several years at Sandoz, where she progressed through roles from CMC Regulatory Affairs Associate II to CMC Regulatory Affairs Associate IV, accumulating a total of five years of experience. Her earlier roles included positions at Sun Pharmaceutical Industries and Abbott Laboratories, where she gained extensive experience in regulatory compliance and product approvals.
Educational Background in Chemistry
Amita Gavaskar earned her Master of Science degree in Analytical Chemistry from the Institute of Science-University of Bombay. This educational foundation provided her with essential knowledge and skills that are applicable in her regulatory affairs career, particularly in the areas of product formulation and compliance with regulatory standards.
Expertise in Regulatory Affairs
Amita Gavaskar specializes in regulatory affairs with a focus on Chemistry, Manufacturing, and Controls (CMC) strategy planning and management. She has hands-on experience with regulatory submissions, including IND and NDA filings, and conducts GAP analysis and risk assessments to streamline approval processes. Her expertise encompasses a wide range of dosage forms, including solid oral, liquid oral, sterile injectables, and transdermal delivery systems. She is well-versed in FDA, GMP, ICH, and EMA guidelines.
Technical Proficiency and Tools
Amita Gavaskar possesses technical proficiency in various regulatory tools and databases, including Veeva Vault, SPL, eCTD, Trackwise, and SharePoint. Her experience includes compiling periodic reports, annual reports, amendments, and supplements, as well as reviewing deficiency letters and managing responses to regulatory inquiries. This technical skill set supports her effectiveness in managing regulatory affairs throughout the product lifecycle.