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.

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 inRegulatoryAffairs
Graduate research courses
HSCI 6263Biostatistics Transl Research
HSCI 6264Epidemiology Translational Res
Strategic leadership courses
HSCI 6223Topics -Health Care Leadership
HSCI 6240Issues & Trends in Health Syst
HSCI 6241The Health Care Enterprise
One of the following:
CML 6274Health Economics and Finance
CRA 6203Partnerships w/Human Subjects
CRA 6208International Clinical Rsrch
CRA 6209Monitoring Clinical Research
CRA 6210MedicalWriting/ClinicalResrch
HCQ 6201Building a Quality Culture

Transfer credits

Up to six credits of previously earned graduate-level coursework may be accepted as transfer credit. Contact the program office for the full policy and guidelines.

Official transfer credit evaluations are conducted only for admitted students.