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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; a foundational knowledge of regulatory affairs, with a focus on regulatory legislation; an appreciation for ethics for professionals in the life science industries; and an understanding of current good manufacturing processes.
This program is also a great way to get started on your Master’s in Regulatory Affairs from San Diego State University.
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:
- Pharmaceuticals
- Manufacturing
- Biologics
- Medical Devices
- Research and Development
- Quality Control/Quality Assurance
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
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 continuous education. The curriculum focuses on the 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 skills they gained by earning an Advanced Certificate in Regulatory Science from San Diego State University.
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Click here for information about our drop policy.
To earn your Advanced Certificate in Regulatory Affairs, you’ll need to complete all four of the courses listed below with a GPA of 3.0+ or better. Each course is three (3) units and costs $3,300.
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
Course List
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. If you’re interested in taking courses individually for professional development, please email regsci@sdsu.edu as they require permission from the graduate advisor.
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.
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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.
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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.
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Once registration opens for your courses, you can register in the my.SDSU portal.
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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
Attend an Application Workshop for tips on successfully applying to SDSU Global Campus.
Upcoming Workshops
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 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.
- Visit Interfolio and look for SDSU’s Advanced Certificate in Regulatory Science, where you will upload the following:
Your 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.
- Applicant Essay: Please provide an essay, that is no longer than a total of two 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.
- 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
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-8225
- 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.
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
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.
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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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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 program?
You can transfer up to 3 units into the advanced certificate program.
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Can I transfer courses from the advanced certificate program into SDSU’s Master of Regulatory Affairs program?
If you complete all four courses (12 units) in the advanced certificate program as an admitted SDSU student, all four courses (12 units) can be transferred into the master’s program. However, if you take courses before being admitted to the certificate program, only three courses (9 units) can be transferred into the master’s program.
Please contact us if you have questions about transferring courses into our 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? Fill out the form on our website to connect with the SDSU Global Campus Welcome Center.
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Related Links
Regulatory Affairs Programs Brochure
Certificate Programs
