Regulatory science professionals are in demand. A career in regulatory affairs can take many paths, e.g., clinical trials, drug development, food safety, medical device advancement, pharmaceutical research, or chemistry manufacturing and controls. Students in SDSU's Master of Science, and Advanced Certificate in Regulatory Affairs programs build foundational knowledge on laws, regulations, and good manufacturing processes mandated by the Food and Drug Administration (FDA) and its international counterparts. Courses are delivered fully online as nine-week special sessions, designed to afford students a high degree of flexibility in integrating their studies with work and other commitments.

Applications Now Open!
Fall 2023: Oct. 1, 2022 - July 1, 2023

Interested in applying? SDSU no longer requires GRE/GMAT testing for admission to any graduate program.

Regulatory Affairs professionals work to ensure that drugs, biologics, and medical devices are safe and effective for human use and meet regulatory standards set by FDA and international regulatory agencies. If you are a student in the life sciences, this may be the career for you - and SDSU’s regulatory science programs can get you started!

SDSU's Master of Science and Advanced Certificate in Regulatory Affairs programs can help you build foundational knowledge on laws, regulations, and good manufacturing processes mandated by the Food and Drug Administration (FDA) and its international counterparts. Courses are delivered fully online as nine-week special sessions, designed to afford students a high degree of flexibility in integrating their studies with work and other commitments.

“

People who are in the industry and hiring employees look to SDSU students as value-added. They know that SDSU students are coming out of our program well educated and capable.

- Kim Walker, M.S., RAC, FRAPS M.S., RAC, FRAPS
Program Instructor & Alumna 2006
Global Regulatory, Quality, & Clinical Consultant

Learn From Regulatory Experts

The Center for Regulatory Science is located in SDSU's College of Sciences. Established in 1999, the Center for Regulatory Science at San Diego State University has provided online education to promote professional excellence and career opportunities for professionals in the pharmaceutical, biotechnology and medical device industries, and those considering making a career change into these fields.

For more information, please visit regsci.sdsu.edu, call (619) 594-2283 or email regsci@sdsu.edu.

Master of Science in Regulatory Affairs

This WASC-accredited program focuses on laws, regulations, and good manufacturing processes mandated by regulatory agencies, such as the FDA. You’ll acquire an advanced knowledge of current regulations and learn how to apply them to the development and commercialization of drug, biologic, and medical device products.

$36,704

Total Estimated Cost
$992 Total Cost/Unit

1.5 Years

Min. Completion Time

Online

Course Format

View Program Details

Advanced Certificate in Regulatory Affairs

The Advanced Certificate is a four-course subset of the MS degree program. It’s designed to help you build a foundational knowledge of regulatory science, get a jumpstart on your master’s degree, and earn a valuable graduate-level certificate from San Diego State University.

$11,904

Total Estimated Cost
$992 Total Cost/Unit

5 Months

Min. Completion Time

Online

Course Format

View Program Details

If you are an international student, you may pursue the degree from your home country or within the U.S. at the same tuition rate as local students. However, the Regulatory Science program does not sponsor F1 student visas.

Students can enroll in courses before being admitted to the University. Three courses (9 units) can be transferred into the RA master's program and one course (3 units) can be transferred into the RA advanced certificate program. Please contact us for more details on transferring courses.

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Courses

2023 Spring2023 Summer2022 Fall2023 Winter
R A 0601 Pharmaceutical, Biotechnology, and Medical Device Industries
Pharmaceutical, biotechnology, and medical device industries. Company organization and product development and commercialization associated activities, e.g., drug discovery, chemical synthesis, quality assurance, regulatory affairs, manufacturing, control, and marketing.
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R A 0602 Food and Drug Law
Laws governing drug, biological, and medical device products. Discussion of Federal Food, Drug, and Cosmetic Act, U.S. Public Health Service Act, Title 21 Code of Federal Regulations, and various amendments.
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R A 0605 Medical/Scientific Writing for Life Science Professionals
Writing for development of a new drug or biologic. Emphasis on effective writing of project reviews, research, reports, protocols, and CTDs.
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R A 0696.01 Introduction to Electronic Submissions
Current issues and topics in regulatory affairs evaluated and discussed. Recent developments and changes in selected areas of regulatory affairs presented by faculty and industry professionals. May be repeated with new content. Maximum credit six units applicable to the master of science degree in regulatory affairs.
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R A 0696.02 Pre-Approval Inspections
Students learn the requirements for hosting successful US FDA Pre-Approval Inspections (PAI) for small and large molecules, how to effectively interpret and apply current Good Manufacturing Practices (cGMPs), and the differences between FDA and EU requirements for the manufacture and control of pharmaceuticals.
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R A 0696.03 Regulatory Intelligence/Strategy
Regulatory intelligence involves gathering, monitoring, analyzing, and communicating regulatory information. This intelligence shapes regulatory strategy for product development and submission routes. This course develops the skills of regulatory affairs professionals to prepare and use regulatory intelligence to develop regulatory strategy recommendations.
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R A 0696.04 Drug and Device Product Development and Regulation in Europe and the U.S.
Advances in biotechnology, medical technology, and information technology give new hope for advancements in disease treatment. This course will introduce you the fundamentals of drug and device development in the U.S. and Europe. It offers exposure to regulations in terms of the approach, the attitude to risk-taking, and the cultural divide. Topics will give you a firm grasp on development from lab to bedside, and provide tools for you to:
  • Describe the major steps of the drug and device development process from bench to bedside
  • Compare and contrast U.S. and European Union regulatory and quality requirements
  • Discuss the basics of a quality management system
  • Develop a product profile for a drug, device, or therapy
  • Draft the basic components of a development plan for a Phase 1 clinical trial, including a preclinical plan, a clinical trial protocol, and CMC (chemistry, manufacturing, and controls) plan
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R A 0705 Project Planning for the Biomedical Industry
Complexity of biomedical product development. Projects and strategies for effectively planning and managing them. Understanding and utilization of management and planning strategies as applied to these biomedical product development projects. Strategies for planning, scheduling, and effective management of regulatory affairs activities and related tasks associated with development of a biomedical product. (Offered only as a distance education course.)
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R A 0750 Leadership for Change and Continuous Improvement
Change management as it relates to strategic planning and quality improvement to increase competitive advantage. Controlling and facilitating change utilizing quality and statistical tools and concepts, and process improvement methods, as applied to management and leadership challenges and production and manufacturing issues.
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Instructors
Lorah Bodie
R A 0770 Current Good Manufacturing Practice
Current Good Manufacturing Practice regulations to assure quality of marketed products. Application to manufacturer's organization, personnel, facilities, equipment, control systems, production, process controls, laboratory procedures and records.
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R A 0772 Post-Approval Activities
FDA and FTC rules and regulations governing advertising, labeling, and promotion for biologics, generic, over-the-counter, and prescription drugs; and medical devices. Annual reporting requirements, changes to approved marketing applications, Good Manufacturing Practice inspections, post-marketing adverse reaction reporting, product recalls, and risk management.
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R A 0773 Medical Device Regulations
Overview of laws and FDA regulations for medical devices, in vitro diagnostics, radiological devices, FDA jurisdiction, registration, listing, labeling requirements, classification, Investigational Device Exemptions (IDE), pre-market approval (PMA), and pre-market notification [510(k)]. (Offered only as a distance education course.)
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R A 0774 Investigational and Marketing Applications for Drugs and Biologics
Content, planning, requirements, and strategy for developing and preparing Food and Drug Administration regulatory submissions to include biologics license applications (BLA), device premarket applications (PMA), device premarket notifications (510[k]), investigational device exemptions (IDE), investigational new drug applications (IND), new drug applications (NDA). Combination product submissions, future submission trends, and risk management. Maximum combined credit six units of Regulatory Affairs 773 and 774 applicable to a master’s degree.
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R A 0775 Clinical Trials: Issues in Design, Conduct, and Evaluation
Issues and requirements in design, conduct, and evaluation of clinical trials for new drugs, biologics, and medical devices. Introduction to biostatistics. (Offered only as a distance education course.)
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R A 0778 Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices
Quality and compliance functions in biotechnology and pharmaceutical companies to include out-of-specification results, developing product specifications, and writing compliant process deviations. Good Laboratory Practices (GLPs). Graded approach for Active Pharmaceutical Ingredients (APIs) manufacturing. Biologics, drugs, and medical device regulations. Quality control (QC) role vs. quality assurance (QA) role. Current trends in industry.
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R A 0779 International Regulatory Affairs
International medical device regulations pertaining to pharmaceuticals, biologics, and devices. Emphasis on European union and other appropriate areas of the world.
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R A 0781 Ethics for Life Science Professionals
Ethical issues confronting health care professionals. Moral positions concerning impact on laboratory animals, human subjects, patients, and consumers, both on a case-specific level and as applied to the field in general. Develop capacities to generalize, translate, and apply principles and ideas to modern biomedical practice.
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R A 0783 Effective Communication for Regulatory Science
Advanced interpersonal, oral, and written communication strategies for the regulatory affairs business environment. Audience analysis, barriers to entry, and cultural considerations. Communication types to include e-mail communications, executive summaries, informational documentation, persuasive arguments, researchbased paper, and visuals for presentations. Culminating effort is capstone paper and presentation.

Prerequisite: Regulatory Affairs 605.
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R A 0797 Project/Thesis Research
Research in the area of regulatory sciences. Maximum credit six units applicable to a master's degree.
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Instructors
Lorah Bodie
R A 0798 Special Study: R A 798
Individual Study. Maximum credit six units applicable to a master's degree.
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