Master of Science 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.
English Language Proficiency (TOEFL, PTE, IELTS, iTEP).
Please contact the institute for more information.
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Students take rigorous graduatelevel courses at KGI in applied biomedical sciences including core regulatory courses, advanced electives, and professional development.
- Two three-month rotation projects at City of Hope will consist of one or a combination of the following:
- Writing and submission of clinical trial protocol and consent to COH regulatory bodies
- Preparation of a pre-IND package or parts of an IND, including the Investigators Brochure (IB)
- Review of material/data to be included in the regulatory material and assessment of data requirements and completeness
- Input in drug development (i.e., participation in team meetings where pre-clinical development is being discussed and evaluated) Students choose projects from the following rotation departments at
- T Cell Therapy Clinical Manufacturing
- Clinical & Translational Project Development
- CAR T Therapy Program
- Office of IND Development and Regulatory Affairs
- Translational Development Center
Scholarships & funding
Several scholarship options are available. Please check the university website for more information.
Tuition fees for the course:
- Semester fee - $20,700
- Yearly fee - $41,400
MSRA learning objectives
- Develop a thorough understanding of the regulatory review steps in the life of a clinical trial protocol, from concept review to submission to the FDA
- Strengthen the understanding of regulatory strategy and review processes, from INTERACT or pre-IND to IND submission to the FDA
- Write a clinical trial protocol starting from a template
- Assess the literature, identify knowledge gaps, and convey findings to the scientific community
- Communicate effectively in an industry environment composed of scientists, engineers, and business professionals
- Contribute productively on an interdisciplinary team tackling complex problems
What can I do with this degree?
There is a wide variety of careers in the regulatory affairs field. Regulatory professionals carry titles such as:
- Regulatory affairs specialist
- Regulatory affairs manager
- Regulatory affairs director
- Compliance specialist
- Food safety inspector
- Clinical research associate
- Director of quality assurance
About this institute
Keck Graduate Institute
Keck Graduate Institute (KGI) in Claremont, California offers a variety of innovative graduate programs and certificates that integrate life sciences, health sciences, genetics, engineering, and business with a focus on industry projects, internships, and team collaborations....
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