A masters in regulatory affairs teaches you how to manage the safety of pharmaceuticals, medical devices, and medical research.
You can learn how to manage global processes that help organizations develop marketing approval for healthcare or food safety products.
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Professionals in this field often go on to work for agencies or manufacturers. Due to their expertise, they usually pursue careers in food, drug, and medical equipment regulation.
Online Masters in Regulatory Affairs Programs
There is a growing need to better regulate products due to the evolving methods of business decision-making and policies.
As a result, there is an increased demand for regulatory affairs professionals who can understand and navigate these policies. Being able to navigate these evolving policies allows organizations to bring regulated products to the market.
The knowledge and skills of regulatory affairs professionals make them highly employable and essential to any organization they join. A master’s degree in regulatory affairs will expose you to compliance requirements regarding the development and marketing of food, medical devices, and pharmaceutical drugs.
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Those who pursue a masters degree in regulatory affairs usually pursue careers as regulatory affairs managers, though they’re not limited to this occupation. Many prospective students already have a career in a related field. Regulatory affairs professionals go on to pursue a range of positions.
Potential career paths in this field include:
- Compliance officer
- Internal auditor
- Regulatory coordinator
- Regulatory scientist
- FDA inspector
- Quality assurance and control manager
There are likely additional career opportunities you may consider since these programs teach a variety of valuable skills. You’ll also encounter many subjects to help you develop these skills, including:
- Clinical research
- Ethics
- Legal concerns
- Quality systems
In addition, a master’s degree in regulatory affairs will generally let you to pick from a variety of concentrations so you can expand your knowledge in your preferred area of specialty.
Common Online Master’s in Regulatory Affairs Concentrations
A master’s program in regulatory affairs may require you to choose a concentration at some point in your education. Here are some sample concentrations to give you an idea of what options may be available to choose from:
- Biopharmaceutical Regulatory Affairs. This concentration teaches you how to drive marketing approval applications for biological and pharmaceutical products.
- Clinical Research Regulatory Affairs. You can learn how to apply regulatory requirements in service of both clinical and animal research.
- Quality Assurance and Compliance. This concentration focuses on the development of regulations for healthcare and food products.
- Clinical Research. This track provides you with a knowledge of the FDA product lifecycle.
- Medical Device Regulatory Affairs. You can learn how to drive marketing approval applications for regulatory agencies and medical device products.
Every program has its own requirements and concentrations. The above list is only a guide to introduce you to common specialization areas.
Regulatory Affairs Careers & Salaries
Attaining a master’s degree in regulatory affairs can help you qualify for senior or leadership positions across organizations. These programs are designed for recent graduates and working professionals alike.
Should you choose to pursue a master’s degree in regulatory affairs, you may choose from a variety of career opportunities. According to the Bureau of Labor Statistics, here are some of the types of positions related to regulatory affairs.
| Careers | Annual Median Salaries |
| Regulatory Affairs Managers (Included in Managers, All Other) | $124,650 |
| Industrial Production Managers | $103,150 |
| Project Management Specialists | $94,500 |
| Occupational Health and Safety Specialists | $77,560 |
| Accountants and Auditors | $77,250 |
| Compliance Officers | $71,650 |
| Occupational Health and Safety Technicians | $51,120 |
| Quality Control Analysts (Included in Science Technicians, All Other) | $49,030 |
| Agricultural Inspectors | $45,140 |
| Quality Control Inspectors | $38,580 |
Many factors contribute to the hiring process, so having a degree in regulatory affairs doesn’t guarantee a certain position or salary.
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For graduate students who already work within healthcare and pharmaceuticals, a masters program in regulatory affairs can help them elevate their existing careers. As such, it’s common for graduates to work as regulatory managers, specialists, and coordinators.
Master of Regulatory Affairs Curriculum & Courses
A master’s in regulatory affairs program can include courses that expose you to every aspect of the product lifecycle. Here are some sample courses to give you an idea of what to expect:
- Drug Discovery, Development, and Regulations: You’ll learn about the process of drug discovery as well as the development process and the regulations involved.
- Global Regulatory Affairs: In this course, you’ll learn about the regulatory authorities and guidelines that determine the marketing and approval of medical products.
- Legal Aspects of Clinical Research: This course exposes you to a variety of topics related to legal issues, informed consent, liability, and more.
- Translational Research in Drug Discovery and Development: This course introduces you to the history of the discovery of new drugs and their application to the treatment of medical conditions.
- Fundamentals of Regulatory Affairs: You’ll learn about both the national and international regulatory systems as well as how to perform modern clinical research.
- Post-Approval Maintenance of Drugs, Biologics, and Devices: You’ll be introduced to the many responsibilities sponsors have upon approval of a drug.
- Health Care Project Management: You can learn about what it takes to be a capable project manager within the health care field.
- Medical Device Development and Regulation: You’ll learn the framework for regulation throughout the product lifecycle.
- Technical Writing for the Regulatory Professional: You can learn how to become a better writer within the regulatory profession.
- Pharmaceutical Safety and Risk Management: You’ll learn about the factors that influence pharmacovigilance and risk management.
Courses can vary depending on the school and program, but you’ll likely encounter some courses similar to these.
Admissions Requirements
The specific admissions requirements for a master’s degree in regulatory affairs can vary from school to school. Here is a list of common requirements for graduate programs:
- Bachelors degree
- Statement of purpose
- Letters of recommendation
- Official undergraduate transcript
- Minimum 3.0 GPA, on average
Some programs require you to have a degree or work experience in a related field, so it’s beneficial to do your research before applying. Masters programs may also ask you to submit GRE or GMAT scores, though a growing number of schools no longer require this.
Accreditation
Accreditation is the process by which a college or university must pass a series of exams and evaluations from an accrediting agency. This status attests to the institution’s high standard of education. Regional accreditation is the most widely recognized accreditation.
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Attending an accredited university can help ensure that you receive a solid education, but it can also be an eligibility factor for receiving financial aid. An accredited degree could also increase your marketability in the job field.
Financial Aid and Scholarships
Many graduate students seek additional funding to help them cover the upfront cost of their education. One of the most common forms of financial aid is student loans from the federal government. You can fill out the Free Application for Federal Student Aid (FAFSA) to apply and see if you qualify for need-based aid.
You can check with your state as well to see what aid programs they offer for students. You can also pursue scholarships or grants. These can be available from a range of sources, including your prospective school and public or private organizations. You’re generally required to apply and fulfill certain criteria to be considered.
If you’re currently employed, you can also see if your employer offers any tuition benefits for professional development.
What Is a Masters in Regulatory Affairs?
A masters in regulatory affairs is designed to further your expertise in all aspects of the pharmaceutical and medical product development process.
Upon graduation, you may have the skills to help develop, distribute, and market these regulated products. This type of program develops both your hard and soft skills. You can become familiarized with the policies that determine how a product is regulated before it reaches the market. You can also develop your leadership skills, written skills, presentation skills, and critical thinking abilities.
A regulatory affairs masters program can help you understand the value of prioritizing safety and quality in each product.
What Can You Do with an Online Masters in Regulatory Affairs Degree?
A regulatory affairs masters program can help you further your expertise and professional qualifications in this growing field.
Graduates with a masters in regulatory affairs may enter positions in regulatory agencies. They may be responsible for overseeing the development and distribution of highly regulated products, such as pharmaceuticals and medical devices. Many graduates fulfill these responsibilities by taking jobs as regulatory coordinators.
Professionals in this field may also work as quality assurance managers, regulatory scientists, compliance officers, FDA inspectors, and internal auditors.
How Long Is a Master in Regulatory Affairs Program?
A masters degree in regulatory affairs can generally be completed in 1 to 2 years with full-time study. A program that consists of around 36 credit hours or less could potentially be completed in 1 year if you study year-round, including during the summer.
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Programs that require a thesis will often take longer to complete. While online programs may offer accelerated tracks, they may also allow you the flexibility to go at your own pace. Part-time studies will typically extend the length of your program.
What’s the Difference Between a Masters Degree in Regulatory Affairs vs. Regulatory Science?
Regulatory affairs and regulatory science are industries that share some practices and methodologies.
| Masters in Regulatory Affairs | Masters in Regulatory Science |
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While a masters program in regulatory affairs and a masters program in regulatory science have some overlap in their curriculum, they also have key differences.
What’s the Difference Between Regulatory Affairs vs. Quality Assurance?
Regulatory affairs and quality assurance share some overlap, but the following chart helps point out some of their differences.
| Regulatory Affairs | Quality Assurance |
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It’s helpful to choose the program that’ll get you closer to your specific career goals.
Is a Masters in Regulatory Affairs Worth It?
Yes, a masters in regulatory affairs is worth it for many students. Having expertise in regulatory affairs could help you qualify for senior or leadership positions in an organization.
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Regulatory affairs specialists are also in high demand in the current job market. For instance, the Bureau of Labor Statistics projects 4% job growth for compliance officers over the next ten years, which is as fast as average. Regulatory affairs management positions are expected to have steady growth as well.
Universities Offering Online Masters in Regulatory Affairs Degree Programs
Methodology: The following school list is in alphabetical order. To be included, a college or university must be regionally accredited and offer degree programs online or in a hybrid format.
Arizona State University offers a Master of Science in Regulatory Science. This program may be an excellent fit for individuals interested in safety-related careers in medical research, pharmaceuticals, or medical device development.The curriculum consists of 33 credit hours. Classes meet 100% online, and each one is 7.5 weeks long.
ASU is accredited by the Higher Learning Commission.
Chapman University offers a fully online program for a Master of Science in Regulatory Affairs. Students can select an emphasis on either Medical Devices or Biopharmaceuticals. The program can be attended either full-time or part-time. Many graduates pursue regulatory careers in pharmacies, biotechnology, the medical device industry, regulatory agencies, or research organizations.
Chapman University is accredited by the Western Association of Schools and Colleges, Accrediting Commission for Senior Colleges and Universities.
The Master of Science in Health Sciences program at George Washington University offers a concentration in Regulatory Affairs. This interdisciplinary program combines concepts from health sciences, business administration, public health, and laboratory science fields. The program is housed entirely online. Most students can complete the degree requirements in 24 months of part-time attendance.
GW is accredited by the Middle States Commission on Higher Education.
Massachusetts College of Pharmacy and Health Sciences offers a Master of Science in Regulatory Affairs and Health Policy. Potential courses include Health Epidemiology, International Regulatory Affairs, and Statistics in Clinical Research. The program is housed 100% online and offers full-time or part-time attendance options. Incoming students can select one of three yearly start dates.
MCPHS is accredited by the New England Commission of Higher Education.
Northeastern University offers a Master of Science in Regulatory Compliance. The curriculum is designed to prepare students to serve in vital regulatory roles in fields like healthcare, life science, and clinical research. Students can complete the degree conveniently online. Tracks are available in Healthcare Compliance, Clinical Research, and Quality and Regulatory Science.
Northeastern University is accredited by the New England Commission of Higher Education.
St. Cloud State University offers a Master of Science in Regulatory Affairs and Services. Students interested in regulatory careers in the medical device industry may find an ideal next step in this program. The program requires the completion of 33 credits. Students can attend classes full-time or part-time synchronously online or on campus in the evening and on weekends.
St. Cloud State University is accredited by the Higher Learning Commission.
Temple University offers a primarily online program for a Master of Science in Regulatory Affairs and Quality Assurance. The curriculum covers key concepts like benefit-risk assessment, domestic and global regulation, data mining, and statistics. Students must complete a minimum of 36 credit hours to graduate. Many graduates pursue careers in the pharmaceutical, device, and biotechnology industries.
Temple University is accredited by the Middle States Commission on Higher Education.
The Master of Science in Biotechnology program at the University of Maryland Global Campus offers a concentration in Biotechnology Regulatory Affairs. Potential classes include Preclinical and Clinical Research Design, Societal Issues in Biotechnology, and Foundations of Project Management. The 36-credit curriculum is housed fully online. Students may transfer in up to 6 qualifying credits from outside institutions.
University of Maryland Global Campus is
The University of Pennsylvania offers a Master of Regulatory Affairs. Individuals who are passionate about innovative design and have a talent for policy enforcement may find an excellent fit in this program. Students can typically complete the degree in 2 years of part-time attendance. The curriculum consists of 10 classes, all of which meet online.
The University of Pennsylvania is accredited by the Middle States Commission on Higher Education.
The University of Southern California offers a Master of Science in Regulatory Science. Graduates of the program often pursue careers in drug safety, research, and development, clinical trials management, or quality assurance and control. All classes are housed online. Students attending full-time can often finish the degree requirements in 2 years, while part-time students can typically complete the program in 3 years.
USC is accredited by the Western Association of Schools and Colleges.
Getting Your Regulatory Affairs Masters Online
You might be interested in regulatory affairs if you have a passion for assuring the quality and safety of drugs, food, and medical products.
Earning a masters in regulatory affairs online could be a strategic way to begin or advance your career in this field. You could develop versatile skills that are applicable to regulatory affairs positions, especially within the medical and pharmaceutical industries. This career field is currently in demand, with continued growth expected over the next decade.
If you’re ready to take this next step in your professional development, you can get started by researching accredited universities that offer masters programs in regulatory affairs.
