Swati Mitra
About Swati Mitra
Swati Mitra is a Senior Manager in Regulatory Affairs and Chemistry, Manufacturing, and Controls (RA CMC) at CytomX Therapeutics, where she has worked since 2019. She has extensive experience in regulatory affairs, having previously held positions at Gilead Sciences, Biocon, and Thermo Fisher Scientific.
Work at CytomX Therapeutics
Swati Mitra has been serving as Senior Manager in Regulatory Affairs Chemistry, Manufacturing, and Controls (RA CMC) at CytomX Therapeutics since 2019. In this role, she oversees regulatory strategies and ensures compliance with industry standards. Her expertise contributes to the development and approval of innovative therapeutics, aligning with the company's mission to advance next-generation antibody-drug conjugates.
Previous Experience at Gilead Sciences
Before her current position, Swati Mitra worked at Gilead Sciences as RA-CMC from 2014 to 2019. During her five years in Foster City, CA, she focused on regulatory submissions and compliance for pharmaceutical products, enhancing her skills in navigating complex regulatory environments.
Educational Background in Molecular Biology
Swati Mitra earned her Master's degree in Molecular Biology from San Jose State University (SJSU) between 1999 and 2002. This academic foundation provided her with a strong understanding of biological processes, which is essential in her regulatory roles within the biotechnology sector.
Career Path and Experience in Regulatory Affairs
Swati Mitra has a diverse career in regulatory affairs, beginning with her role at Biocon as an International Regulatory Affairs professional from 2010 to 2013 in Bangalore, India. She also held positions at Stellartech Research, Affymetrix, and Thermo Fisher Scientific, where she gained extensive experience in quality assurance and product development.
Certification in Regulatory Affairs
In addition to her Master's degree, Swati Mitra completed a Certificate in Regulatory Affairs from the University of California, Santa Cruz (UCSC) Extension. This certification further solidified her expertise in regulatory processes and compliance, supporting her roles in various organizations.