Regulatory Affairs, M.S.

Specific Requirements

In addition to meeting the requirements for classified graduate standing and the basic requirements for the master’s degree as described in Requirements for Master’s Degrees , the student must complete a graduate program consisting of a minimum of 37 units as follows:

Required Courses

Complete 31 units of required courses.

R A 601 - Pharmaceutical, Biotechnology, and Medical Device Industries Units: 3
R A 602 - Food and Drug Law Units: 3
R A 605 - Medical/Scientific Writing for Life Science Professionals Units: 3
R A 750 - Leadership for Change and Continuous Improvement Units: 3
R A 770 - Current Good Manufacturing Practices - General Concepts Units: 3
R A 773 - Medical Device Regulations Units: 3
or
R A 774 - Investigational and Marketing Applications for Drugs and Biologics Units: 3 But not both.
R A 775 - Clinical Trials: Issues in Design, Conduct, and Evaluation Units: 3
R A 779 - International Regulatory Affairs Units: 3
R A 781 - Ethics for Life Science Professionals Units: 3
R A 783 - Effective Communication for Regulatory Science Units: 4

Electives

Complete six units of electives from the following courses.

R A 696 - Advanced Topics in Regulatory Affairs Units: 1-4
R A 705 - Project Planning for the Biomedical Industries Units: 3
R A 772 - Post-Approval Activities Units: 3
R A 773 - Medical Device Regulations Units: 3
or
R A 774 - Investigational and Marketing Applications for Drugs and Biologics Units: 3 But not both.
R A 778 - Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices Units: 3
R A 797 - Research Units: 1-3
R A 798 - Special Study Units: 1-3