Graduates of the MSRA program 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 in regulatory affairs.
The Master of Science in Regulatory Affairs (MSRA) is a two-year Keck Graduate Institute (KGI)–City of Hope (COH) joint program. The MSRA 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).
Students take courses at KGI in the first year of the program, and in the second year, they complete two three-month rotation projects at COH.
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 in regulatory affairs.
This master’s is also a career change program for current employees in quality control or quality assurance.
In year one, students take rigorous graduate-level courses in applied biomedical sciences at KGI.
In year two, students conduct two three-month rotation projects at COH, gaining exposure to a multitude of regulatory affairs practices.
Students interact with multiple regulatory and operational bodies that oversee regulatory and clinical trial activities.
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 stage of product development.
In the drug, medical device, and biologic product industries, these phases include:
In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.
Average yearly salary for regulatory professional
increase in job listings in the past four years
Projected industry growth until 2026
There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:
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