Regulatory Affairs, MRA

The objective of the Master of Regulatory Affairs (MRA) degree program is to produce a cadre of highly trained and sophisticated practice professionals adept in the skills necessary to maximize compliance and minimize risk in the development of FDA regulated products. Students will learn both the foundation and application of science-based clinical investigation and the corresponding regulation. The program is designed to meet these objectives through didactic course work and an experiential capstone project.


Students must complete 10 course units and achieve a B- or higher for all course work counted toward the degree. The MRA program is a fully online program.
Core Requirements
REG 5100Introduction to Clinical and Translational Research1
REG 6100Fundamentals of FDA Regulation1
REG 6120Introduction to Drug Development1
REG 6190Research Ethics in Regulatory Affairs1
REG 6400Capstone I1
REG 6410Capstone II1
Advisor-approved electives3
Concentration Courses
Concentration requirements1
Total Course Units10



General Concentration
REG 6150Post-Approval Maintenance of Drugs, Biologics, and Devices1
Total Course Units1

Clinical Research

Clinical Research Concentration
REG 6110Clinical Trial Management1
Total Course Units1

Quality Assurance

Quality Assurance Concentration
REG 6160Quality Assurance1
Total Course Units1

The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2023 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.