Regulatory Affairs, M.S.

(Major Code: 49045) (SIMS Code: 779901)

Offered in partnership with the Center for Regulatory Science in the College of Sciences and SDSU Global Campus

Advancement to Candidacy

All students must satisfy the general requirements for advancement to candidacy, as described in Requirements for Master’s Degrees .

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
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 701 - Regulatory Intelligence/Regulatory Strategy Units: 2
R A 702 - Pre-Approval Inspections Units: 1
R A 703 - Introduction to Electronic Submissions Units: 3
R A 705 - Project Planning for the Biomedical Industries Units: 3
R A 761 - Drug/Device Product Development and Regulation in Europe and the US Units: 1
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
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