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.


The degree and major requirements displayed are intended as a guide for students entering in the Fall of 2026 and later. Students should consult with their academic program regarding final certifications and requirements for graduation.


 

Curriculum

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
Capstone
REG 6400Capstone I1
REG 6410Capstone II1
Electives
Advisor-approved electives 13
Concentration Courses
Concentration requirements1
Total Course Units10
1

Courses selected in consultation with advisor. 

Concentrations

General

REG 6150Post-Approval Maintenance of Drugs, Biologics, and Devices1

Clinical Research

REG 6110Clinical Trial Management1

Quality Assurance

REG 6160Quality Assurance1
Plan of Study Grid
First Year
FallCourse Units
REG 5100 Introduction to Clinical and Translational Research 1
REG 6120 Introduction to Drug Development 1
 Course Units2.00
Spring
REG 6400 Capstone I 1
REG 6190 Research Ethics in Regulatory Affairs 1
 Course Units2.00
Second Year
Fall
Elective 1
Concentration Course 1
 Course Units2.00
Spring
REG 6410 Capstone II 1
Elective 1
 Course Units2.00
Summer
REG 6100 Fundamentals of FDA Regulation 1
Elective 1
 Course Units2.00
 Total Course Units10.00