Kruti Patel, Msra
About Kruti Patel, Msra
Kruti Patel is a Quality Associate II at Mammoth Biosciences in Brisbane, California, with a background in regulatory affairs and quality assurance. She has worked in various roles in the pharmaceutical industry, including internships and positions in India and the United States.
Current Role at Mammoth Biosciences
Kruti Patel currently serves as a Quality Associate II at Mammoth Biosciences in Brisbane, California. She has been in this position since 2022, contributing to quality assurance processes within the organization. Her role involves ensuring compliance with regulatory standards and maintaining quality control in the development of bioscience products.
Previous Experience in Quality Assurance
Before her current role, Kruti Patel worked as a Quality Assurance Associate at Mammoth Biosciences starting in 2021. Her earlier experience includes a position as a Junior Associate at Advantmed from 2017 to 2018, where she gained foundational skills in quality assurance. Additionally, she completed an internship at InvaDerm Pharma Solutions, further enhancing her expertise in this field.
Educational Background in Drug Regulatory Affairs
Kruti Patel earned her Master of Science in Drug Regulatory Affairs from Northeastern University, where she studied from 2019 to 2021. Her academic focus included international regulatory frameworks for drugs, biologics, and medical devices. She also holds a Bachelor of Pharmacy degree from LJ Institute of Pharmacy, where she achieved a CGPA of 8.07 from 2013 to 2017.
Internship Experience in Regulatory Affairs
Kruti Patel has completed several internships that provided her with practical experience in regulatory affairs. Notably, she interned at China Med Device in 2021 for three months and at Freyr Solutions in 2019 for two months. These roles allowed her to develop skills in regulatory intelligence and strategy, including familiarity with eCTD modules and ANDA submissions.
Knowledge of Regulatory Bodies and Compliance
Kruti Patel possesses knowledge of various international regulatory bodies, including the European Medicines Agency (EMA), Therapeutic Goods Administration (TGA), Central Drugs Standard Control Organization (CDSCO), and Pharmaceuticals and Medical Devices Agency (PMDA). She is experienced with US FDA regulations and has a solid understanding of the US legislative system as it pertains to drug regulatory affairs.