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

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.

Advanced Certificate

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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.

$36,704

Total Estimated Cost
$992 Total Cost/Unit
Textbooks not Included

1.5 Years

Min. Completion Time

Fully Online and Mostly Asynchronous

Course Format

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
  • Manufacturing
  • Biologics
  • Medical Devices
  • Research and Development
  • 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
Regulatory Affairs Managers — Nationwide

Job Postings
517
Job postings last 12 months

Projected Growth
+2%
Projected Growth Over 10 years

Salary Range
$111,734
Average Salary


Source: Burning Glass/Emsi, 2022

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.

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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

Required Courses (31 Units)

Elective Courses (6 Units)

Elective Courses (6 Units) Units Spring Summer Fall
RA 696: Advanced Topic in Regulatory Affairs (1-4 Units)
Regulatory Intelligence/Strategy (2 Units)
GXP Audits (1 Unit)
Pre-Approval Inspections (1 Unit)
 
2
1
1
     
RA 705: Project Planning for the Biomedical Industry 3      
RA 772: Post-Approval Activities, Including Advertising, Promotion and Labeling 3      
RA 778: Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices 3      

RA 773 or RA 774 may also be taken as an elective, if not taken as a required course.

Open Courses

RA 601 and 602 are open to all students. No application is necessary for either open course. The term/block that our courses are offered in is listed in the table below. View the Academic Calendar for course dates and registration deadlines. Each course costs $1,812.

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.

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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.

  1. Once 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.

  2. 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.

  3. Once registration opens for your courses, you can register in the my.SDSU portal.

  4. Complete your full payment in my.SDSU after your registration has been submitted. You will need to submit your full payment within 48 hours from the date you registered for your course.  If you do not submit your payment within the specified time frame, you will be dropped from your classes.

Click here for more details on registration

How to Apply

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.

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:

  1. Apply to the University through Cal State Apply.
  2. 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
  3. Materials for Regulatory Affairs Department
    • The following materials should be emailed to regsci@sdsu.edu:
      • Two Letters of Recommendation
        • These letters should come from professors, supervisors or business associates who can knowledgeably discuss 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 Essay
        • This essay should include a description of your long- and short-term career goals, and the ways in which you believe this degree will help you to achieve them.
      • 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.

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Frequently Asked Questions

Will my degree say “online”?

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.

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How is the program structured?

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.

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What is the program format?

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.

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Can I enroll in courses before I apply?

Yes! Both RA 601: Pharmaceutical, Biotechnology, and Medical Device Industries and RA 602: Food and Drug Law are open to anyone interested. No application is required to take either course.

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Can I transfer courses I’ve already taken into the master’s program?

You can transfer up to 9 units into the master’s program.

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What else does SDSU Global Campus offer?

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.

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I’m interested. How do I get started?

Ready to take the next step? Click here to connect with the SDSU Global Campus Welcome Center.

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Related Links

Regulatory Affairs Programs Brochure

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Want To Learn More?

Tell us who you are, the best way to reach you, and your message and we'll be in touch to answer all your questions and explain the next steps in the process.

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