Master of Science in Regulatory Science

USC School of Pharmacy

The Master of Science in Regulatory Science program aims to provide alternative career preparation in an underserved area of science called regulatory science.

Most graduates work in industry or government to facilitate the development of medical products or foods by working with regulatory agencies and strategically positioning the engineering, chemical, animal and clinical trials activities needed for product approval.

Coursework is held non-traditionally in a combination of intensive day long classroom experiences and distance modules, so that participants from industry and government can take part in the coursework while working full-time. This provides a rich and varied classroom experience for a student body that is a mix of experienced and new professionals, and many students who already have other advanced degrees. The program is very flexible. Students can start in fall, spring or summer and take courses year-round.

Career Options

Typically students enter careers in regulatory affairs, clinical development, risk management, quality assurance or business development.

Sample Courses

Introductory
MPTX511 Introduction to Medical Product Regulation 3 units

Advanced Regulatory (2 of the following)
MPTX512 Regulation of Drugs and Biologics 3 units
MPTX513 Regulation of Medical Devices 3 units
MPTX514 Regulation of Food and Dietary Supplements 3 units

Quality
MPTX515 Quality Assurance 3 units

Clinical
MPTX517 Structure and Management of Clinical Trials 4 units

Biostatistics
MPTX522 Clinical Design Course 3 units

Law
MPTX516 Medical Products and the Law 3 units

Business
RSCI 601 Biomedical Commerce 4 units

Internship (International Students see below*)
MPTX630 Directed Field Research Project 6 units

Total units of required coursework 32 units

Elective Courses offered by the Regulatory Science Program (four units minimum)

MPTX518 Medical Writing 3 units
MPTX519 International Approaches to 3 units Regulation
RSCI 520 Risk Management 2 units
RSCI 521 Seminar in Regulatory Science 1 unit
MPTX524 Food Science and Technology 3 units
RSCI 525 Introduction to Drug and Food Toxicology 3 units
MPTX526 Chemistry Manufacturing Control 3 units
RSCI 527 Medical Product Safety 3 units
RSCI 528 Safety in Health Care Environment 3 units
RSCI 529 Risk Management Tools and Techniques 2 units
MPTX530 Translational Medicine: An Overview 2 units
MPTX531 Drug Discovery 4 units
MPTX532 Early Stage Development 3 units
MPTX590 Directed Research 1-6 units
MPTX602 Science, Research, and Ethics 2 units

Total units for degree completion = 36 units