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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.

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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.

Estimated CostTotal Estimated Cost
$36,704

Textbooks not included
Completion Time Min. Completion Time
As short as 1.5 years
Course Format Course Format
Online

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.

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Program is perfect for

SDSU’s online Master of Science in Regulatory Affairs program is designed for professionals who currently work with regulations and want to take their career 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 Device Production
  • Research and Development

Graduates have used their degree 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. All courses in the Advanced Certificate can be applied to the master’s program.

What you can 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.

Course topics include:

  1. Introduction to the Pharmaceutical, Biotechnology and Medical Devices Industries
  2. Food and Drug Law
  3. Investigational and Marketing Applications for Drug and Biologics
  4. Medical Device Regulations
  5. Current Good Manufacturing Practices
  6. International Regulatory Affairs
  7. Medical and Scientific Writing, and Effective Communication
  8. Leadership for Change and Continuous Improvement
  9. Clinical Trials: Issues in Design, Conduct and Evaluation
  10. Ethics for Life Science Professionals
  11. Electives include:
    • Regulatory Intelligence/Strategy
    • Post-Approval Activities
    • Project Management
    • Electronic Submissions
    • QC/QA
    • GxP Audits
    • Pre-Approval Inspections
    • and more

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.

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Outcomes

Labor Analysis
Regulatory Affairs Manager — Nationwide

Job Postings
Job Postings
Last 12 months
6,237

Projected Growth
Projected Growth
Over 10 years
+8%

Salary Range
Salary Range
Average
$64,500-$132,200


Source: BLS & Burning Glass Technologies, 2020

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.

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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 and 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. And by starting with SDSU’s Advanced Certificate in Regulatory Affairs program, you can work towards your master’s degree without taking the GRE.

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

RA 601: Pharmaceutical, Biotechnology and Medical Device Industries (3 Units)
RA 602: Food and Drug Law (3 Units)
RA 605: Medical & Scientific Writing for Life Science Professionals (3 Units)
RA 750: Leadership for Change and Continuous Improvement (3 Units)
RA 770: Current Good Manufacturing Practices – General Concepts (3 Units)

RA 773: Medical Device Regulations (3 Units)
or
RA 774: Investigational and Marketing Applications for Drugs and Biologics (3 Units)

RA 775: Clinical Trials: Issues in Design, Conduct and Evaluation (3 Units)
RA 779: International Regulatory Affairs (3 Units)
RA 781: Ethics for Life Science Professionals (3 Units)
RA 783: Effective Communication for Regulatory Science (4 Units)

Elective Courses — 6 Units

RA 696: Advanced Topic in Regulatory Affairs (1-4 Units)

  • Various “hot topic” courses in Regulatory Affairs. Possible offerings include:
    • Regulatory Intelligence/Strategy (2 Units)
    • GXP Audits (1 Unit)
    • Pre-Approval Inspections (1 Unit)
RA 705: Project Planning for the Biomedical Industry (3 Units)
RA 772: Post-Approval Activities, Including Advertising, Promotion and Labeling (3 Units)
RA 778: Quality Control and Quality Assurance: Pharmaceuticals, Biologics, and Medical Devices (3 Units)

 

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

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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:

  • 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.
  • 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.
  • 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. Create your SDSU WebPortal Account after receiving your Red ID number
  3. 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 92182-7416
      • 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 your SDSU WebPortal account under Upload Admission Documents.

  4. 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 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 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
        • The 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.

Cost

  Unit Cost Program Unit Range* Cost
Tuition $931 37 $34,447
Fees
Associated Students $19 37 $703
Technology $21 37 $777
Student Engagement $21 37 $777
Total Estimated Costs $992   $36,704

* Everyone is unique, your admissions advisor will work with you to determine the right path that suits your needs.

The current total cost of earning your Master’s in Regulatory Affairs online is $35,150 (subject to change). Students are responsible for the cost of textbooks and applications. Financial aid is readily available.

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