KGI Announces the Master of Science in Regulatory Affairs—A New Degree Program to Enroll in Fall 2021

Keck Graduate Institute (KGI), a leader in biotechnology and healthcare graduate education, is partnering with City of Hope (COH) to launch a second joint master’s degree: The Master of Science in Regulatory Affairs (MSRA).

The MSRA program aims to provide students with translational and applied experience in regulatory affairs for all FDA-regulated product classes (drugs, biologics, and devices) throughout the product lifecycle (pre-clinical development, clinical development, and post-marketing). The program expects to enroll its first cohort in fall 2021.

“One of the distinguishing features of the MSRA program is that students will have the opportunity to interact with multiple regulatory and operational bodies that oversee regulatory and clinical trial activities,” said Anastasia Levitin, KGI professor of practice in translational medicine.

Students in the MSRA program will take rigorous graduate-level courses in applied biomedical sciences at KGI during the first year and complete two three-month rotation projects at COH in the second year.

“Our MSRA students will have unique hands-on experiences at the City of Hope Comprehensive Cancer Center in developing new drugs or drugs being optimized in clinic,” said City of Hope’s Yilun Liu, MSRA co-program director.

Career prospects for a regulatory affairs professional are promising. The average yearly salary is $150,422, and there has been a 40-percent increase in job listings in the past four years.

MSRA program graduates will be uniquely positioned to begin careers in regulatory affairs and quality assurance for biotech and pharma companies, academic research, programs with regulatory functions, or continue onto doctorate programs.

Regulatory affairs deal with the government and Food and Drug Administration quality and performance standards, ensuring that the therapeutics, devices, and other healthcare tools abide by such standards. Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each product development stage.

The MSRA program is the second joint program between KGI and City of Hope: The Master of Science in Translational Medicine program graduated its first cohort in May 2020.

The Master of Science in Regulatory Affairs is currently accepting applications for fall 2021. For more information, including admissions requirements, visit kgi.edu/msra.