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.

The Center for Regulatory Science is located in SDSU's College of Sciences. For program information visit regsci.sdsu.edu, where you can see the requirements for the master's degree and advanced certificate, course descriptions, and application information. For any additional questions, call (619) 594-0845 or email regsci@sdsu.edu.

International students may pursue the degree from their 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. Four courses (12 units) can be transferred into the RA master's program and one course (3 units) can be transferred into the RA advanced certificate program.

To accommodate the ongoing COVID-19 pandemic, we've temporarily extended or relaxed some of the application requirements for our graduate degree and advanced certificate programs. We want to ensure that all students can apply for our programs, even if they are currently unable to schedule tests or report transcripts.

Please review the official policy change notice from the Division of Graduate Affairs to learn how these changes may affect your application process.

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.

Estimated Cost Estimated Cost
$35,150
Textbooks not included
Completion Time Min. Completion Time
1.5 Years
Course Format Course Format
Online

Advanced Certificate in Regulatory Affairs

The Advanced Certificate is a four-course subset of the MS degree program. All courses are transferable to the MS degree.

Estimated Cost Estimated Cost
$11,400
Textbooks not included
Completion Time Min. Completion Time
5 Months
Course Format Course Format
Online

Labor Analysis
Compliance Manager — Nationwide

Job Postings
Job Postings
Last 12 months
26,518

Projected Growth
Projected Growth
Over 10 years
+8%

Salary Range
Salary Range
Average
$70,000-$106,000

 

Introductory courses (RA 601& RA 602) are open to all. For all other courses, students currently enrolled in the program will receive their registration links via email from the Regulatory Science department. Individuals interested in these courses for professional development should email regsci@sdsu.edu.

Courses

2020 Spring2020 Summer2020 Fall
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.
Course Date(s)

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Instructors
Norma J Schafer
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.
Course Date(s)

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Instructors
Scott Harris
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.
Course Date(s)

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Instructors
Linn Bekins, Rita Tomlin
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.
Course Date(s)

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Instructors
Mitchell Seymour
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.
Course Date(s)

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Instructors
Kadambi A Ajit-Simh
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.
Course Date(s)

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Instructors
Mary E Wilhelm
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
Course Date(s)

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Instructors
Kimberly A Walker, Norma J Schafer, Kadambi A Ajit-Simh
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.)
Course Date(s)

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Instructors
Yekaterina Yurievna Sharikova
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.
Course Date(s)

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Instructors
Lisa Dowdy
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.
Course Date(s)

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Instructors
Kadambi A Ajit-Simh
2020 Summer
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.
Course Date(s)
May 18 - July 19
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Instructors
Norma J Schafer
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.)
Course Date(s)

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Instructors
Kimberly A Walker
R A 0774 Investigational and Marketing Applications for Drugs, Biologics, and Medical Devices
Development and informational content for investigational new drug applications (IND), investigational device exemptions (IDE), new drug applications (NDA), product license applications (PLA), and biologics license applications (BLA) for FDA review. (Offered only as a distance education course.)
Course Date(s)

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Instructors
Norma J Schafer
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.)
Course Date(s)

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Instructors
Bernard D King
2020 Summer
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.
Course Date(s)
May 18 - July 19
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Instructors
Kadambi A Ajit-Simh
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.
Course Date(s)

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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.
Course Date(s)

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Instructors
Darrel Moellendorf
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 602.
Course Date(s)

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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.
Course Date(s)



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2020 Summer
R A 0798 Special Study: R A 798
Individual Study. Maximum credit six units applicable to a master's degree.
Course Date(s)
May 18 - July 19
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Instructors
Lisa Dowdy