Master of Science in Health Sciences in the Field of Regulatory Affairs

The master of science in health sciences in the field of regulatory affairs degree program is designed to prepare graduates to facilitate and lead change and innovation in regulatory practice. Throughout the program, students will develop strategies for integrating business needs into regulatory strategic planning and will learn to evaluate the scientific and economic value of bringing new health care products to the global market.

The program helps prepare its graduates to:

  • Lead and collaborate with all involved functions and stakeholders for effective development of medical products;
  • Develop a broad understanding of the philosophies and roles of the domestic and international regulatory agencies that oversee drug, biologic, device and diagnostic development;
  • Provide strategic direction, integrating business needs in matters of regulatory science and affairs.

The Master of Science in Health Sciences in the field of Regulatory Affairs (RAFF) requires successful completion of 36 credits, including: 9 credits of the research coursework, 6 credits of strategic leadership courses, 18 credits in the field of regulatory affairs, and a 3-credit elective course.

Required
Regulatory affairs courses
RAFF 6201Introduction to Global Regulatory Affairs
RAFF 6202Regulatory Drug Biologics
RAFF 6203Regulatory Device Diagnostics
RAFF 6204Clinical Research for Regulatory Affairs
RAFF 6205Regulatory Affairs Compliance
RAFF 6275Leadership in Regulatory Affairs
Graduate research courses
HSCI 6263Biostatistics Translational Research
HSCI 6264Epidemiology Translational Research
Strategic leadership courses
HSCI 6223Topics in Health Care Leadership
HSCI 6240Issues and Trends in the Health Care System
HSCI 6241The Health Care Enterprise
Electives
One of the following:
CML 6274Health Economics and Finance
CRA 6203Partnerships with Human Subjects
CRA 6208International Clinical Research
CRA 6209Quality and Risk Management
CRA 6210Medical Writing/Clinical Research
HCQ 6201Building a Quality Culture