Vaibhavi Chokshi Rac
About Vaibhavi Chokshi Rac
Vaibhavi Chokshi is an Associate Director of CMC Regulatory Affairs at Sangamo Therapeutics, Inc., with extensive experience in regulatory submissions and compliance strategies. She holds a B.Pharm and two Master's degrees in Pharmacy and Regulatory Science, and has worked in various biotech companies, specializing in cell and gene therapy.
Work at Sangamo Therapeutics
Vaibhavi Chokshi Rac serves as the Associate Director of CMC Regulatory Affairs at Sangamo Therapeutics, Inc. since 2022. In this role, she is responsible for overseeing regulatory strategies and ensuring compliance with industry standards. Her work involves managing regulatory change control processes, which are critical for maintaining adaptability in regulatory approaches. Sangamo Therapeutics is located in Brisbane, California, where Rac contributes to the company's focus on innovative therapies.
Education and Expertise
Vaibhavi Chokshi Rac holds a Bachelor of Pharmacy (B.Pharm) from NIRMA University, where she studied from 2003 to 2007. She furthered her education by obtaining a Master of Science in Regulatory Science from the University of Southern California from 2016 to 2018. Additionally, she earned a Master's degree in Pharmacy from SVKM's Narsee Monjee Institute of Management Studies (NMIMS) from 2007 to 2009. Rac specializes in regulatory submissions across various applications, including IND/CTA, IMPD, NDA/BLA, DMF, IDE, and 510(k).
Background in Regulatory Affairs
Vaibhavi Chokshi Rac has extensive experience in regulatory affairs, having worked in both start-up and large biotech companies. Her career includes positions at Nivagen Pharmaceuticals, Atara Biotherapeutics, and Bachem, where she held roles focused on regulatory compliance and submissions. She also worked at the University of Southern California's International Center of Regulatory Science & SC-CTSI, contributing to regulatory science initiatives. Rac's diverse background provides her with a comprehensive understanding of the regulatory landscape.
Professional Experience
Prior to her current role at Sangamo Therapeutics, Vaibhavi Chokshi Rac held various positions in regulatory affairs. She worked as a Regulatory Affairs Manager at Atara Biotherapeutics from 2020 to 2022 and spent time at Nivagen Pharmaceuticals in 2018. Rac also served as an Assistant Manager in Regulatory Affairs at Intas Pharmaceuticals from 2009 to 2016. Her experience spans over a decade and includes hands-on work with regulatory software tools such as Microsoft Project, Mastercontrol, and Veeva.
Specialization in Cell and Gene Therapy
Vaibhavi Chokshi Rac specializes in regulatory affairs related to cell and gene therapy, particularly focusing on CAR-T, allogeneic, and autologous therapies. This specialization reflects her commitment to advancing innovative therapeutic approaches within the regulatory framework. Her expertise in this area positions her as a knowledgeable professional in the evolving landscape of biotechnology and therapeutic development.