Saurabh Kothari, Msra, Msbe, Mspm, R Ph, Ccrp, Rac
About Saurabh Kothari, Msra, Msbe, Mspm, R Ph, Ccrp, Rac
Saurabh Kothari is the Director of Regulatory Affairs at Evelo Biosciences, with extensive experience in clinical trial documentation and regulatory standards. He also serves as adjunct faculty at Northeastern University and UC San Diego Extension, contributing to the education of future professionals in regulatory affairs and quality assurance.
Work at Evelo Biosciences
Saurabh Kothari currently serves as the Director of Regulatory Affairs at Evelo Biosciences, a position he has held since 2019. In this role, he oversees regulatory strategies and compliance, ensuring that the company's clinical trials and product developments meet the necessary regulatory standards. Prior to this, he worked as the Regulatory Affairs Manager at Evelo Biosciences from 2017 to 2019, where he contributed to the management of regulatory submissions and interactions with health authorities.
Education and Expertise
Saurabh Kothari holds multiple master's degrees, including a Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, completed in 2016, and a Master of Science in Project Management from Harrisburg University of Science and Technology, completed in 2019. He also earned a Master of Science in Biomedical/Medical Engineering and a Bachelor’s Degree in Pharmacy from Birla Institute of Technology and Science, Pilani. His education equips him with a strong foundation in regulatory standards and project management.
Background
Saurabh Kothari has extensive experience in regulatory affairs and clinical trial management. He has worked in various capacities across several organizations, including ARIAD Pharmaceuticals, TIMI Study Group, and Takeda Pharmaceuticals. His roles have included Trial Master File Specialist and Regulatory Affairs Associate, where he gained significant expertise in maintaining clinical trial documentation and regulatory compliance. He also has international experience in pharmacovigilance, enhancing his understanding of drug safety monitoring.
Current Teaching Roles
In addition to his role at Evelo Biosciences, Saurabh Kothari is involved in academia as an Adjunct Faculty member. Since 2022, he has been teaching in the MS Regulatory Affairs Program at Northeastern University in Boston, Massachusetts. He also teaches Quality Assurance at UC San Diego Extension, a position he has held since 2021. These roles allow him to share his knowledge and expertise with students pursuing careers in regulatory affairs and quality assurance.
Professional Experience
Saurabh Kothari has held various positions that have contributed to his expertise in regulatory affairs and clinical trial management. His experience includes working as a Clinical Trial Associate at Premier Research and as a Safety Processing Expert intern at Novartis. He has also worked as a Quality Assurance Inspector II at Boston Scientific. His diverse background in different organizations has provided him with a comprehensive understanding of regulatory processes and quality assurance practices.