Master of Science in Regulatory Affairs
Applications Accepted for:
Fall 2025: Oct. 1, 2024 – June 15, 2025
Click here to view upcoming application and document submission due dates.
SDSU’s online Regulatory Affairs Master’s program will help you obtain an advanced knowledge of current regulations and learn how to apply them to the development and commercialization of drug, biologic, and medical device products.
For details on the Advanced Certificate in Regulatory Affairs program, click below.
- Overview
- Courses
- How To Apply
- Resources
About the Program
Regulatory science professionals are in demand. A career in regulatory affairs can take many paths, such as clinical trials, drug development, food safety, medical device advancement, pharmaceutical research, or chemistry manufacturing and controls. All of these fields need educated professionals with a thorough knowledge of regulations and official processes dictated by the Food and Drug Administration (FDA) and its international counterparts.
SDSU’s Master of Science in Regulatory Affairs program is designed to help meet this demand. Created in collaboration with SDSU’s Center for Regulatory Science, this online master’s program will provide you with a comprehensive background in regulatory science. You’ll also receive additional training that you’ll need to successfully develop, manufacture, and market a wide range of biopharmaceutical, pharmaceutical, and medical device products.
Is This Program Right for Me?
SDSU’s online Master of Science in Regulatory Affairs program is designed for professionals who currently work with regulations and want to take their careers to the next level. The program is also appropriate for individuals in another role in this industry who are interested in transitioning into regulatory affairs. We carefully examine each applicant’s unique background, including their academic preparation, related industry experience, and professional and educational goals.
Students in the program have professional experience in a variety of fields, including:
- Pharmaceuticals
- Biologics
- Research and Development
- Manufacturing
- Medical Devices
- Quality Control/Quality Assurance
Graduates have used their degrees and advanced knowledge of regulations to become directors, managers, and high-level executives throughout the life science industry.
If you’re interested in advancing your career in regulatory science, but you’re not sure if you want to commit to a 1.5-year graduate degree program, the four-course Advanced Certificate in Regulatory Affairs can help you decide if SDSU’s master’s program is the right choice for you.
What Can I Learn?
SDSU’s online Regulatory Affairs Master’s program was created to address the research and workforce needs of companies as they make the transition from research and development to manufacturing and production. This includes the legal, ethical, and regulatory elements that both guide and restrict the industry, including the laws and regulations created by the Food and Drug Administration and other regulatory agencies here and abroad.
Throughout the program, you’ll also develop your leadership abilities, with several lessons that focus on enhancing your ability to communicate with others and manage teams within your organization. An advanced understanding of current regulations, paired with the ability to communicate those regulations at all levels of your organization, will allow you to become a stronger leader and a more well-rounded regulatory science professional.
You’ll need to complete all degree requirements within seven (7) years of starting your coursework in order to earn your degree.
Career Outcomes
Labor Analysis
M.S. In Regulatory Affairs Graduate — Nationwide
- 15,075Job Postings in the last 12 months
- 5%Projected job growth in the next 10 years
- $128,463Average salary of graduates
Source: Bureau of Labor Statistics, 2024
Top Industries Regulatory Affairs Managers
- Manufacturing – 45.6%
- Professional, Scientific, and Technical Services – 23.1%
- Finance and Insurance – 12.1%
- Healthcare and Social Assistance – 9.6%
- Other – 9.6%
According to the Bureau of Labor Statistics, there were more than 6,000 jobs across the country seeking regulatory affairs managers, and those numbers are expected to grow by 8% over the next decade. The median annual salary for regulatory affairs managers is over $96,000. Annual salaries for those who hold a master’s degree can range from $77,000 to more than $116,000 per year. 45% of all regulatory affairs managers work in manufacturing, with another 23% working in professional, scientific, and technical services.
Why Should You Choose Us?
Reputation
When you join SDSU’s online regulatory science degree program, you’re joining a reputable community of professionals who are passionate about regulatory affairs. As a member of that community, you’ll have the opportunity to enhance your professional network by forging lasting connections with your classmates, professors, and program alumni. Graduates hold high-level positions with top organizations throughout the public sector, academia, and the business world, including Johnson & Johnson, Bayer, Boston Scientific, Kimberly-Clark, and the Mayo Clinic.
Accessibility
Earning your Master of Science in Regulatory Affairs online allows you to earn a valuable degree without putting your career on hold. Most of the courses are self-paced, which means that you can work towards earning your degree when it’s convenient for you. You can earn your degree in as little as 18 months, but you’ll have up to seven (7) years to complete all the required coursework.
Practicality
Your curriculum is continuously updated to include the latest rules and regulations from governing bodies throughout the world. You’ll pair your lessons with discussions on real-life case studies and regulatory issues that you and your classmates have experienced. And because the coursework is online, you’ll have the ability to apply the lessons that you learn in your job the very next day.
Click here for information about our drop policy.
To earn your M.S. in Regulatory Affairs from SDSU, you’ll need to complete the following:
- 31 Units of Required Courses
- 6 Units of Electives
Summer 2024 Term Dates
May 20-August 12, 2024
Fall 2024 Term Dates
Block 1: August 19-October 20, 2024
Block 2: October 14-December 15, 2024
Spring 2025 Term Dates
Block 1: January 21-March 23, 2025
Block 2: March 17-May 18, 2025
RA 601: 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.
RA 602: 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.
RA 750: 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.
RA 770: Current Good Manufacturing Practices – General Concepts
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.
RA 773: 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.)
RA 774: 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.
RA 775: 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.)
RA 779: International Regulatory Affairs
International regulations to include those in the European Union and other key areas of the world that pertain to the development and commercialization of biologics, medical devices, and pharmaceuticals.
RA 781: 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.
RA 783: 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.
R A 0798 Special Study: R A 798
Individual Study. Maximum credit six units applicable to a master’s degree.
RA 790: Regulatory Affairs Practicum
| This course is designed to provide graduate students with practical regulatory affairs experience within the pharmaceutical, biologic, medical device, in vitro diagnostic device industry or regulatory authority environments under the instruction of a faculty-mentor and organization host-site supervisor. During the semester, students will work directly with regulatory affairs professionals to extend their professional development and give them an opportunity to apply the regulatory affairs concepts they have learned in the classroom. This course can provide up to a maximum credit of three (3) elective units to be applied to the Master of Science in Regulatory Affairs degree. |
RA 605: Effective Regulatory Writing and Communication
| In this course, students will learn written, oral, and interpersonal communication strategies for regulatory affairs professionals. Audience analysis will be discussed, as well as cultural considerations in communication. Students will develop an appreciation of the role writing plays in regulatory affairs and develop confidence using writing as a communication tool. Barriers to communication (e.g., using words or terms the audience does not understand, writing in distant passive voice, vagueness, etc.) will be discussed. Students will also learn to design effective visuals for presentations. |
RA 696: Dietary Supplement Regulations
| Overview of laws and regulations for Total Product Lifecycle management of Dietary Supplements (DS) in the US and the EU. Topics covered will include DS clinical trial requirements, pre-market submissions (i.e., NDIs, Structure/Function Claims, Qualified Health Claims, etc.), establishment registration, listing, labeling requirements, strategic considerations, and post-market requirements. This course will provide a comprehensive introduction to the regulatory affairs requirements related to the Dietary Supplement industry. |
RA 696-C: Clinical and Performance Evaluation Reports for Medical Devices and IVDs
| This elective course will provide details on how to write a European Union (EU) Medical Device Regulation (MDR) compliant Clinical Evaluation Report (CER) and In Vitro Diagnostic Medical Device Regulation (IVDR) compliant Performance Evaluation Report (PER). Best practices for communicating with Notified Bodies (NBs) related to non-conformances will also be reviewed. |
Required Courses (31 Units)
RA 696: 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.
RA 696.02: 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.
RA 705: 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.)
RA 772: Post-Approval Activities, Including Advertising, Promotion and Labeling
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.
RA 778: 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.
RA 696-D: Drug and Biologic Clinical Trial Management
| This elective course will provide an in-depth review of best practices in managing drug and biologic clinical trials for Regulatory Affairs professionals. |
RA 696-E: Global Pharmacovigilance
| This elective course, offered as part of the Regulatory Science Program in the College of Sciences at San Diego State University, will introduce and familiarize students with global drug and biologic pharmacovigilance, with a focus on US and EU regulations, and provide an overview of the drug adverse event lifecycle. The course will cover the journey of the adverse event from first intake to the communication of risks, including the potential for drug recall. Risk management and good pharmacovigilance practices will be shared along with some real-world examples. The course will also discuss best practices on how to respond to FDA or EMA requests for additional information and review some of the most common regulatory authority requests. |
RA 696-F: Human Cell and Tissue (HCT/P) Product Regulations
| This course provides an overview of laws and regulations for Total Product Lifecycle management of human cell, tissue, and cellular and tissue-based product (HCT/P) in the US. Topics covered will include HCT/P clinical trial requirements, pre-market submissions, establishment registration, Good Tissue Practice, GMPs, labeling requirements, strategic considerations, and post-market requirements. This course will provide a comprehensive introduction to the regulatory affairs requirements related to the HCT/P industry. |
RA 696-G: Medical Device and IVD Clinical Trial Management
| This elective course will provide an in-depth review of best practices in managing medical device and in vitro diagnostic (IVD) device clinical trials for Regulatory Affairs professionals. |
RA 696-H: Oncology Drug Development
| This elective course, offered as part of the Regulatory Science Program in the College of Sciences at San Diego State University, will introduce and familiarize students with the global oncology drug development process, with a focus on US and EU regulations. The course will discuss the unique details related to oncology drug development and discuss the FDA and EMA oncology drug initiatives. |
RA 696-I: Statistics for Regulatory Affairs
| This elective course will provide an overview of statistical analysis techniques relevant to Regulatory Affairs professionals. Analytical (non-clinical data) and clinical data statistical analysis that is relevant to pre- and post-market drug, biologic, medical device, and in vitro diagnostic (IVD) products will be discussed. |
RA 703: Introduction to Electronic Submissions
| This course will provide an introduction to current and future elements of electronic submissions for drug, biologic, and device submissions to health authorities. Electronic Common Technical Document (eCTD) and eCopy format will be covered. The course includes software instruction and a practicum to give students the opportunity to create content, assign content to an XML backbone, hyperlink documents, and validate compliance. NOTE: This course requires purchase of docuBridge ONE software (PCs only) and Adobe Acrobat Professional. |
RA 720: Variable Topics Course
| Covers Hot Topics in the Regulatory Affairs industry. |
RA 761: Drug/Device Product Development and Regulation in Europe and the US
| This course covers the basic concepts of drug/device development, and regulatory and quality requirements in Europe and the US. It provides exposure to emerging professions in the life science industry and builds skills interacting with these professionals in international environments. |
Elective Courses (6 Units)
RA 773 or RA 774 may also be taken as an elective, if not taken as a required course.
Open Courses
All courses are open to students except for RA 783 and RA 798. Please contact righellis@sdsu.edu for an evaluation and to receive permission on the courses you would like to take.
Once you’re ready to register, click the Enroll button below to begin the registration process for open courses.
Please note that if you want to earn the Advanced Certificate (meaning it will appear on your SDSU transcript), you must submit an application and be accepted into the program. Students taking only open courses will not receive an Advanced Certificate.
If you plan on applying to the program, only two open courses can be retroactively applied to your transcript. You’ll need to complete the other two courses after you’re admitted. Courses taken before you’re admitted will count as special session credits and are not eligible for financial aid. Only courses taken after you are accepted and matriculated are financial aid eligible.
How to Register for Open Courses
Starting in the spring 2023 semester, SDSU Global Campus is using a new registration process for open courses. Please follow the instructions below to successfully enroll in courses.
Once you’ve received a department evaluation (contact righellis@sdsu.edu) and you’ve chosen your courses, click the Enroll button below to begin the registration process. Please indicate on the form that you’d like to register for courses.
Once you’ve filled out the Enrollment form, you’ll receive a confirmation email from SDSU Global Campus within 2-3 business days with the next steps to complete your enrollment.
Once registration opens for your courses, you can register in the my.SDSU portal.
Complete your full payment in my.SDSU after your registration has been submitted. Click here for more information on our payment and drop policy.
How to Apply
Attend An Application Workshop For Tips On Successfully Applying To SDSU Global Campus.
Out-of-State Applicants
While we welcome out-of-state students, SDSU Global Campus currently cannot accept applications from students residing in some specific states. Please check back often, as this list of approved states does change. View the list of authorized states here.
International Applicants
Please click here for detailed guidance on how to submit your transcripts.
Admission Requirements
Successful applicants to SDSU’s online Master of Science in Regulatory Affairs program will generally possess a background in the life or physical sciences, or engineering. However, all highly motivated students with a strong interest in regulatory science are encouraged to apply.
You should also meet all the minimum SDSU requirements at the time of enrollment:
- You should hold an acceptable baccalaureate degree earned at an institution accredited by a regional accrediting association, or have completed equivalent academic preparation as determined by the graduate dean.
- You should have attained a grade point average of at least 2.85 in an acceptable earned baccalaureate degree, or at least 2.85 in the last 60 semester (90 quarter) units attempted, or hold an acceptable post-baccalaureate degree earned at an institution accredited by a regional accrediting association.
- You should have been in good standing at the last institution you attended.
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.
If you’re interested in taking courses individually for professional development, please email regsci@sdsu.edu. Both introductory courses (RA 601 and 602) are open to all students, while other courses require permission of the graduate advisor.
You can also enroll in a course before being formally admitted to SDSU — you’re able to transfer three courses (up to 11 units) into the master’s program.
We understand that every student’s academic journey is unique, and we encourage you to contact one of our Student Service Representatives to find out what you’ll need to successfully apply to the program.
Application Instructions
To apply for the online Master of Science in Regulatory Affairs, you’ll need to complete the following steps:
- Apply to the University through Cal State Apply.
- Submit materials to SDSU Graduate Division.
- Official transcripts should be ordered from all post-secondary institutions attended and sent electronically to transcriptsforsdsu@sdsu.edu. Any institutions that are not able to send electronic transcripts should mail them directly to:
Graduate Admissions
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-8225- Students who have completed a degree at SDSU should only submit transcripts for work completed at other institutions since they last attended SDSU.
- Students with international coursework should submit both the official transcript (issued in English or English translation of the transcript) and proof of degree.
- Proof of English Proficiency (if required) — All graduate and post-baccalaureate applicants (regardless of citizenship status) applying to SDSU from an international institution where the medium of instruction was not English, should submit one of the following as proof of English proficiency:
- TOEFL minimum score of 80 iBT/ 550 PBT: Score can be sent electronically from Educational Testing Service (ETS) using the SDSU institution code: 4682. Test score should be from within the past two years.
- IELTS overall score of 6.5 or higher: Score report should be submitted directly to the SDSU Graduate Admissions Office. Test score should be from within the past two years.
- Duolingo English Test score of 105 or higher: Score can be sent electronically from Duolingo, to the SDSU Graduate Admissions Office. Test score should be from within the past two years.
- PTE minimum score of 58 or higher: Score report should be submitted directly to the SDSU Graduate Admissions Office. Test score should be from within the past two years.
- A copy of your official score report or unofficial transcript can be submitted through my.SDSU
- Official transcripts should be ordered from all post-secondary institutions attended and sent electronically to transcriptsforsdsu@sdsu.edu. Any institutions that are not able to send electronic transcripts should mail them directly to:
- Visit the links below and look for SDSU’s regulatory Affairs (MS) – Global Campus where you will upload the following:
- Fall 2025 Application – Deadline June 15, 2025
- Two Letters of Recommendation
- These letters should come from professors, supervisors or business associates who can discuss knowledgeably your leadership and academic abilities, accomplishments and potential. This form should be used for letters of recommendation. These recommendations should be sent directly from the recommender to the email address provided above.
- Applicant EssayYour essay should have four sections that correspond to the elements above. Please note that grammar, clarity of writing, concise writing, typos, omissions, and spelling will be evaluated.
- Please provide an essay, that is no longer than a total of 2 pages, addressing each element listed below:
- Why are you pursuing a Master’s in Regulatory Affairs? (Or for the Certificate program – Why are you pursuing an Advanced Certificate in Regulatory Affairs?)
- What are your short-term career goals and how do you believe this program will help you achieve these goals?
- What are your long-term career goals and how do you believe this program will help you achieve these goals?
- Provide any important information you think would help the committee better understand your academic performance, personal history, or professional history.
- Please provide an essay, that is no longer than a total of 2 pages, addressing each element listed below:
- Résumé/CV
- Your résumé should be in reverse-chronological order and include job titles, organizations (nature of business), locations, dates of employment, and a summary of duties and responsibilities for each position held. Please also include a link to your profile on LinkedIn.
After submitting the online Cal State Apply application, you will receive an email from San Diego State University that includes your SDSUid, which is needed to log into my.SDSU. You can use my.SDSU to check your application status, update your contact information, access your financial aid, and more. Please check back frequently to make sure all of the required materials have been received — you’re responsible for ensuring that all supporting materials are submitted by the deadline.
Financial Aid
Important Note: Courses taken before acceptance are not eligible for financial aid. Once you are accepted or matriculated, the courses are financial aid eligible.
This program is approved for financial aid. To begin the financial aid process, visit the Office of Financial Aid and Scholarships website. There, you’ll be able to access the Free Application for Federal Student Aid (FAFSA).
We encourage you to apply for financial aid as soon as possible.
Frequently Asked Questions
No, it won’t. Upon graduation, you’ll have earned the same master’s degree as if you had completed your studies in person — a Master of Science in Regulatory Affairs from San Diego State University.
Our Master of Science in Regulatory Affairs is fully online and mostly asynchronous, which means you can study and learn mostly on your own schedule. The program consists of required courses and electives that can be completed in as short as one and a half years.
For each course, you can expect to spend on average 12-15 hours per week on coursework and lessons.
Almost all course activities are asynchronous, meaning that you do not have to be online on any particular day/time to participate in the course. Some activities, such as role plays and presentations, may require all students to participate at the same time. There are weekly assignments, including WebExercises and discussion boards based on the weekly readings. You can access weekly lectures online. Written transcripts and mp3 files of the lectures are also available.
Yes! All courses are open to students except for RA 783 and RA 798. Please contact righellis@sdsu.edu for an evaluation and to receive permission on the courses you would like to take. No application is needed to take open courses.
You can transfer up to 9 units into the master’s program.
When you enroll in an academic program at SDSU Global Campus, you’re joining the San Diego State University community even if you’re not on campus. This means that you’ll have access to many of the same services, programs, cultural centers, clubs, and resources that SDSU’s on-campus students enjoy. Click here to learn more.
Ready to take the next step? Click here to connect with the SDSU Global Campus Welcome Center.