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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.
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.
Textbooks not included
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.
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:
- Introduction to the Pharmaceutical, Biotechnology and Medical Devices Industries
- Food and Drug Law
- Investigational and Marketing Applications for Drug and Biologics
- Medical Device Regulations
- Current Good Manufacturing Practices
- International Regulatory Affairs
- Medical and Scientific Writing, and Effective Communication
- Leadership for Change and Continuous Improvement
- Clinical Trials: Issues in Design, Conduct and Evaluation
- Ethics for Life Science Professionals
- 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.
Outcomes
Labor Analysis
Regulatory Affairs Manager — Nationwide
Job Postings
Last 12 months
6,237
Projected Growth
Over 10 years
+8%
Salary Range
Average
$64,500-$132,200
Source: BLS & Burning Glass Technologies, 2020
Top Industries
Regulatory Affairs Managers
Manufacturing
Professional, Scientific, and Technical Services
Finance and Insurance
Healthcare and Social Assistance
Other
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 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.