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About the Program
Created in collaboration with SDSU’s Center for Regulatory Science in the College of Sciences, the Advanced Certificate in Regulatory Affairs program will help you build a solid understanding of the rules and regulations involved in the pharmaceutical, biotechnology, and medical device industries; an appreciation for ethics for professionals in the life science industries; and an understanding of current good manufacturing processes.
All four courses in the online certificate program are transferable to the Master of Science in Regulatory Affairs program — which makes it easier to start earning your Master's in Regulatory Affairs from SDSU.
Is This Program Right for Me?
SDSU’s online regulatory science certificate program is ideal for working professionals who have experience working in fields that must be in compliance with rules and regulations at the state and federal levels.
The program is also appropriate for individuals in other roles in this industry who are interested in transitioning into regulatory affairs.
By earning your Advanced Certificate in Regulatory Affairs, you can become a valuable resource on regulations and required regulatory pathways for your organization. Many graduates use their certificates to become directors, managers, and high-level executives in their respective industries. And because the courses are delivered in an entirely virtual format, you can easily work towards your certificate on your schedule, without putting your professional life on hold.
What Can I Learn?
Earning your Advanced Certificate in Regulatory Affairs will give you the knowledge and the skills you need to ensure that your organization is producing products in compliance with the appropriate laws and regulations. And, you can learn at your own pace.
The Advanced Certificate consists of four nine-week special sessions. Each nine-week online course is designed to integrate easily with your work and other commitments. Many students earn their certificates in as little as five months.
The curriculum will help you build the skills you need to enhance your career in a variety of fields, including:
- Clinical Trials
- Drug and Biologics Development
- Medical Device Development
- Pharmaceutical Research
- Chemistry Manufacturing and Controls
You’ll develop an advanced understanding of the guidances and regulations that the Food and Drug Administration (FDA) and its international counterparts use to ensure that consumers have access to safe and reliable products. You’ll also focus on current good manufacturing processes, ethics for life science professionals, and food and drug law.
Your courses are taught by expert faculty from SDSU’s Center for Regulatory Science. Their knowledge, combined with a cutting-edge curriculum, will help you get the most value out of your certificate.
Career Outcomes
Labor Analysis
Regulatory Affairs Specialist — Nationwide
348,700
Job Postings in 2020
+6%
Over 10 years
Source: Burning Glass/Emsi, 2022
Why Should You Choose Us?
Innovation
As a regulatory affairs professional, you know that you must be aware of all current laws and regulations. Staying up-to-date and relevant in a fast-changing field requires a continuous education. The curriculum focuses on interpretation of the latest legislation from the FDA and its international counterparts, which means that you’re never learning outdated information. With an advanced regulatory affairs certification, you can lead innovation across your organization and keep all operations running smoothly.
Community
You’re not just earning a certificate. You’re joining an academic community of professionals who are passionate about regulatory affairs. Your expert instructors bring years of regulatory experience to the classroom, and your classmates come from all types of professional backgrounds. Your collective professional experiences reinforce your lessons. Together, you’ll build a solid foundation of regulatory knowledge based on the science of product development, manufacturing, and the latest public policies.
Reputation
You’ll find SDSU’s graduates leading regulatory efforts for industry-leading institutions all over the world. Many graduates hold high-level positions with top organizations throughout the public sector, academia, and the business world, including Air Liquide, Bausch & Lomb, Genentech, Abbott, and Thoratec. They’ve advanced their careers using the knowledge and the skills they gained by earning an Advanced Certificate in Regulatory Science from San Diego State University.
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To earn your Advanced Certificate in Regulatory Affairs, you’ll need to complete all four of the following courses with a GPA of 3.0+ or better:
- RA 601: Pharmaceutical, Biotechnology, and Medical Device Industries (3 units)
- RA 602: Food and Drug Law (3 units)
- RA 770: Current Good Manufacturing Practices - General Concepts (3 units)
- RA 781: Ethics for Life Science Professionals (3 units)
Students currently enrolled in the program will receive their registration links via email from the Regulatory Science department. Note, RA 601 and 602 are open to all students and registration links for these two courses appear at the bottom of this page.
Course List
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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 Advanced Certificate 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 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 certificate 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, without earning a certificate, please email regsci@sdsu.edu. Both introductory courses (RA 601 and 602) are open to all students, while others require the permission of the graduate advisor.
For all other courses, students currently enrolled in the program will receive their registration links via email from the Regulatory Science department.
You can also enroll in a course before being formally admitted to SDSU — you’re able to transfer two 3-unit courses into the Advanced Regulatory Science Certificate 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 Advanced Certificate in Regulatory Affairs program, you’ll need to complete the following steps:
- Complete an application to San Diego State University through Cal State Apply.
- Please select “Extended Education: Certificate: Regulatory Affairs” when submitting your application.
- Create your SDSU WebPortal Account after receiving your RedID number
- Submit the following:
- 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
Enrollment Services
San Diego State University
San Diego, CA 92182-7416
- If you’ve completed your degree at SDSU, we’ll have this information on file. You’ll only need to submit transcripts for work completed at other institutions since you last attended SDSU.
- If you have international coursework, you’ll need to submit both the official transcript (issued in English or English translation of the transcript) and proof of degree.
- A Résumé/CV detailing work experience and education should be emailed to regsci@sdsu.edu.
Financial Aid
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
Do I receive a letter grade at the completion of the course?
Yes, students in our academic certificate programs receive a letter grade at the completion of the program. You can log in to WebPortal to view grades after you complete each course.
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How is the program structured?
Our Advanced Certificate in Regulatory Affairs is fully online and mostly asynchronous, which means you can study and learn on your own schedule. The program consists of four, nine-week-long required courses which are a subset of the Master of Science in Regulatory Affairs program. All advanced certificate courses can be applied to the Master's degree. You can complete the program and earn your Advanced Certificate in Regulatory Affairs in as little as five months.
For each course, you can expect to spend between 12-15 hours per week (108-135 hours total) on coursework and lessons.
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Is there financial support available for this program?
The Advanced Certificate in Regulatory Affairs program is eligible for financial aid.
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How do I receive my Advanced Certificate once I’ve finished the program?
Once you have completed all the program requirements, email regsci@sdsu.edu and request your Certificate to be processed and mailed to you.
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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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