Vidhi Dharia
About Vidhi Dharia
Vidhi Dharia is a Manager in Global Regulatory Affairs CMC at Kite Pharma, where she has worked since 2022. She holds a Master's degree in Biotechnology from SRM University and has extensive experience in regulatory affairs, having previously worked at GSK and Novavax.
Work at Kite Pharma
Vidhi Dharia currently holds the position of Manager, Global Regulatory Affairs CMC at Kite Pharma. She has been with the company since 2022, contributing to regulatory affairs processes in Santa Monica, California. In her role, she manages computerized systems such as GPID, which are essential for regulatory affairs operations. Dharia also initiates and contributes to local process improvements that impact the Regulatory Affairs CMC function and other departments. Her responsibilities include preparing and submitting moderately complex regulatory documents, ensuring compliance with ICH and regional requirements.
Education and Expertise
Vidhi Dharia earned her Master's degree in Biotechnology from SRM University, where she studied from 2010 to 2012. Prior to that, she completed her Bachelor's degree in Biotechnology at St. Francis College for Women, an Autonomous College of Osmania University, from 2007 to 2010. Her educational background provides a strong foundation for her work in regulatory affairs and compliance within the biotechnology and pharmaceutical industries.
Background in Regulatory Affairs
Dharia has extensive experience in regulatory affairs, having worked at GSK in various roles from 2016 to 2021. Her positions included Regulatory Affairs Specialist, Operational Quality Specialist, and Learning and Development Coordinator. In these roles, she prepared and submitted regulatory documents, provided regulatory expertise to submission teams, and contributed to training initiatives. Additionally, she worked at Novavax as a QC Stability Coordinator from 2014 to 2016, further enhancing her expertise in quality control and regulatory processes.
Professional Experience at GSK
During her tenure at GSK, Vidhi Dharia held multiple positions that contributed to her professional development. She served as a Regulatory Affairs Specialist from 2018 to 2021, where she focused on regulatory compliance. Prior to that, she worked as an Operational Quality Specialist and a Learning and Development Coordinator. Her diverse roles at GSK allowed her to gain comprehensive knowledge in regulatory affairs, quality assurance, and training within the pharmaceutical sector.
Research Experience
Before her roles in regulatory affairs, Vidhi Dharia worked as a Research Assistant at Capricorn Pharma Inc. from 2013 to 2014. This position provided her with hands-on experience in research and development, further solidifying her understanding of the biotechnology field. Her research background complements her regulatory expertise, allowing her to navigate the complexities of compliance in the pharmaceutical industry effectively.