Online Master’s in Regulatory Science Programs – Medical Device, Food & Pharmaceutical Regulatory Affairs
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For the 2023-2024 academic year, we have 112 schools in our MHAOnline.com database and those that advertise with us are labeled “sponsor”. When you click on a sponsoring school or program, or fill out a form to request information from a sponsoring school, we may earn a commission. View our advertising disclosure for more details.
“There is a great need for well-trained regulatory professionals who know how to utilize regulatory science to impact human health worldwide.”
Patricia Termini, MS, RAC, Director of the Master of Professional Science in Regulatory Science Program, University of North Carolina Eshelman School of Pharmacy
A master’s degree in regulatory science can prepare students for a career helping biotechnology and bioscience companies navigate the complicated legal and regulatory aspects of healthcare. Because regulations are continually changing, this field is both emergent and dynamic.
Compliance with state and federal laws is essential to biotechnology companies. As they expand internationally, they can expect to encounter new global compliance rules and regulations. To thrive, these businesses need a comprehensive strategy and expert guidance.
The skills and knowledge needed to assist these companies can come from a master’s degree in regulatory science or regulatory affairs. These programs teach professionals how to manage the development of biotechnology products throughout the development, approval, and compliance phases. These programs also offer a unique background for those who wish to pursue careers in health policy with governments, non-governmental organizations, or private consulting services.
The goal of regulations is to keep people safe. Pharmaceutical, biotech, and other health-related businesses share that same goal. A master’s in regulatory sciences can empower graduates to help companies and government regulators work together towards this objective. Additionally, the industry features a diverse range of products, including medical devices, supplements, and pharmaceutical medications. Regulatory affairs is another specialized area that offers exciting career prospects.
Graduates may find themselves in situations where they are helping a potentially life-saving medication gain FDA approval, consulting with an agency to make medical devices safer, managing a top biotechnology research lab, or helping to shape public policy.
The following guide introduces ten online programs specializing in health product regulation and three outstanding educators leading these programs.
| Featured Regulatory Science & Affairs Programs | ||
|---|---|---|
| Arizona State University | Clinical Research Management - Regulatory Science (MS) | View Full Profile |
| Arizona State University | Corporate and Healthcare Compliance (MLS) | View Full Profile |
| Arizona State University | Healthcare Law and Administration (MLS) | View Full Profile |
| Arizona State University | Regulatory Science (MS) | View Full Profile |
| Johns Hopkins University - Advanced Academic Programs | MS Individualized Genomics and Health - Regulatory/Policy | View Full Profile |
| Johns Hopkins University - Advanced Academic Programs | MS Regulatory Science | View Full Profile |
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For the 2023-2024 academic year, we have 112 schools in our MHAOnline.com database and those that advertise with us are labeled “sponsor”. When you click on a sponsoring school or program, or fill out a form to request information from a sponsoring school, we may earn a commission. View our advertising disclosure for more details. |
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Meet The Expert: Patricia Termini, MS, RAC
Patricia Termini is the director of the master’s of professional science (MPS) in regulatory science and an associate professor in the division of pharmacotherapy and experimental therapeutics at the University of North Carolina Eshelman School of Pharmacy. She has over 25 years of experience in the pharmaceutical, biotechnology, and consulting industries focused on regulatory affairs strategy, execution, and project management.
Termini has experience working cross-functionally on pre-approval and post-approval regulatory activities and has worked in multiple therapeutic areas, including dermatology, infectious disease, oncology, and rare diseases. She has an MS degree in regulatory affairs and quality assurance from Temple University, holds a Regulatory Affairs Certification (RAC), and has certificates in drug development and project management.
MHAOnline.com: What is something you wish the public understood about master’s degrees in regulatory science?
Termini: There is a great need for well-trained regulatory professionals who know how to utilize regulatory science to impact human health worldwide. Regulatory professionals use regulatory science to expedite the development of medicinal products that are safe, effective, and of high quality to patients. A great example of regulatory science was the expedited development of products to detect, treat, and prevent illness during the Covid-19 pandemic.
MHAOnline.com: What advice would you give to aspiring students seeking a master’s degree in regulatory science?
Termini: The regulatory profession is a hidden career path that many people are unaware of, with opportunities available in many different sectors of the pharmaceutical and biotechnology industries. If you are a lifelong learner who wants to learn to leverage regulatory science in developing medicinal products that benefit patients, then perhaps a master’s degree in regulatory science is for you.
The UNC Eshelman School of Pharmacy MPS in regulatory science program provides leaders with the regulatory knowledge, professional skills, and practical experience needed to positively impact human health worldwide through the development of new medical products.
Meet The Stephen Amato, PhD, MBA
Dr. Stephen Amato has over 25 years of expertise in the pharmaceutical, biotechnology, and medical device sectors. He is the faculty director of graduate regulatory affairs and life sciences at Northeastern University. Previously, he founded and managed tJûn17 Life Sciences Advisors, LLC, and held a managing director role at Cardinal Health Regulatory Sciences.
In his career before academia, Dr. Amato oversaw global regulatory affairs and reimbursement projects, focusing on market access, pricing, and payer strategies. He also managed the company’s product portfolios, encompassing regulatory and promotional strategies. Earlier, he directed a $140M orthopedic product portfolio at Smith & Nephew Endoscopy and developed genomic diagnostics at Visible Genetics. He also contributed to developing sepsis treatments at Critical Therapeutics.
Dr. Amato holds an AB in biochemical sciences from Harvard University, a PhD in molecular and cellular biology, and an MBA from Boston College. He is certified in US and EU Regulatory Affairs and consults for the Regulatory Affairs Professional Society.
MHAOnline.com: What is something you wish the public understood about master’s degrees in regulatory science?
Amato: Regulatory affairs is a field where you need to be pretty well-rounded. You need to have a solid scientific background, not necessarily at the PhD level, but it helps. You also need to understand how the company you work for is going from a commercialization perspective, which means asking, “How much is it going to cost to develop this product, and what’s going to cost us to market it?” This field is about everything from the very start of product or drug development all the way through writing and filing submissions with regulatory agencies.
MHAOnline.com: What advice would you give to aspiring students seeking a master’s degree in regulatory science?
Amato: One piece of advice I would give is to learn to communicate as effectively as you can, both orally and in writing. Much of what regulatory affairs professionals do is putting together submissions that must be clear to the FDA and other regulatory bodies. If you can’t communicate clearly what you’re submitting, then you’re not going to be very successful.
The second piece of advice I have is to try to make yourself as well-rounded as you can. Get a strong science background, even if it’s just at the bachelor’s level. You’ll need it because, while regulatory affairs professionals are responsible for putting together submissions, they’re not responsible for doing all the writing. They’re responsible for collecting everybody’s piece of the pie and using their knowledge to put it into a cohesive submission.
Featured Programs in Regulatory Science
The featured master’s degree programs below generally require a bachelor’s degree in an allied science, health, or engineering field and demonstrated interest or professional experience in a related industry.
ASU’s clinical research management master’s program with a concentration in regulatory science prepares candidates for expanding roles in managing clinical research. Students learn about regulatory writing techniques, quality systems, and the regulation of pharmaceuticals and medical devices so that they can pursue careers as quality control specialists, clinical research associates, regulatory affairs managers, and regulatory affairs specialists. The program is housed in the College of Nursing and Health Innovation at ASU and combines multiple disciplines so that graduates can successfully lead regulatory compliance of numerous clinical studies.
This 33-credit program includes 15 credits of core courses, 15 credits of concentration classes, and three credits of a capstone project. Examples of concentration topics include medical device development and regulation, clinical research data management and technology implementation, quality assurance and clinical research, pharmaceutical safety and risk management, and technical writing for the regulatory professional.
Admission requirements include a bachelor’s degree in a related subject with a 3.0 GPA and at least six months of work or internship experience in clinical research.
ASU also offers an online master of science in regulatory science and an online MS in regulatory science with a concentration in food safety. Both these programs are made up of 33 credits. The MS in regulatory science includes courses in clinical research design and methods, healthcare project management, and medical device development and regulation. The food safety concentration includes courses such as food safety and protection, regulatory writing, assessing food safety and developing policy procedures and training, and quality assurance for producing food, products, and supplements.
Lastly, ASU’s Sandra Day O’Connor College of Law provides an online MLS (master of legal studies) in corporate and healthcare compliance, helping students build knowledge of legal principles that will be useful for careers in industries where compliance is a major concern. This 30-credit program includes coursework in U.S. law and legal analysis, fundamentals of contract law, tort law, property, conducting fact investigators and reporting, and data privacy and protection.
- Location: Tempe, AZ; Phoenix, AZ
- Accreditation: Commission on Accreditation of Allied Health Education Programs (CAAHEP); Higher Learning Commission (HLC)
- Format: Online
- Expected Time to Completion: 24 months
The Johns Hopkins University online master’s program in regulatory science prepares candidates to keep up with the ever-changing regulations in the biosciences sector and lead compliance strategies. This fully online degree program also provides a hands-on introduction to clinical practices, laboratory practices, manufacturing, and product development.
The ten-course, 40-credit program is divided into six core courses on enterprise and regulatory affairs, one practicum, and three electives in advanced topics in the regulatory approval process of global and national biotech products. Coursework includes an introduction to regulatory affairs, clinical development of drugs and biologics, biological processes in regulatory affairs, and food and drug law. Professionals teach interactive online classes with the Food and Drug Administration (FDA) or industry experience.
Admission requirements are a bachelor’s degree in life sciences or a related subject with a minimum GPA of 3.0 and completion of undergraduate courses in biochemistry and cell biology. Students without the courses above can take two prerequisite courses in bioorganic chemistry and the foundations of bioscience before the program begins. GRE and GMAT scores are not a requirement to apply.
JHU also offers an online MS in food safety regulation, which prepares students for scientific, leadership, or administration positions such as food safety regulatory specialists, consultants, managers, and consumer safety officers.
This 40-credit program includes courses such as an introduction to food safety regulation, food microbiology, food labeling and packaging regulations, food toxicology, and food safety audits and surveillance. Students will examine the roles of pest control, food production and harvesting, food processing, storage and transport, advertising, handling, and production.
- Location: Washington, DC
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Format: Online
- Expected Time to Completion: 20 to 36 months
George Washington University offers several graduate degree options relating to regulatory affairs. These programs include a master’s of science in health sciences (MSHS) program and a graduate certificate. Both programs can be completed entirely online, and no on-campus residencies are required. These programs provide graduates with the expertise to manage the regulatory process for clinical research.
The MSHS in regulatory affairs includes 36 credits where students learn about financial and strategic principles, communication and negotiation skills, and management and leadership techniques for decision-making. The coursework was developed with professionals in regulatory affairs and governmental agencies, including the FDA and NIH. The graduate certificate requires the successful completion of 12 credits.
Program courses include issues and trends in health systems, clinical research for regulatory affairs, the healthcare enterprise, biostatistics for clinical and translational research, epidemiology translational research, introduction to global regulatory affairs, and regulatory drug biologics, among others.
To apply, students must have a bachelor’s degree with at least a 3.0 GPA in a subject related to the medical field and relevant work experience in healthcare or clinical institutions.
Graduates will be ready to take up roles such as regulatory affairs specialists, compliance managers, and quality managers.
- Location: Washington, DC
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Format: Online
- Expected Time to Completion: MSHS (24 months); certificate (12 months)
MCPHS offers an online master of science in regulatory affairs and health policy. The school aims to empower students to keep patients safe through health policy and regulations. The program aims to give students a foundation in the laws and regulations relating to healthcare, drugs, devices, and biologics.
Students take 30 credits over two years, with two electives included in the curriculum. They study various subjects, including FDA and regulatory affairs, law and health policy of drugs and devices, statistics in clinical research, health policy development, and data analysis. Students can enroll in the program part- or full-time based on their needs.
For program entry, applicants must have a bachelor’s degree with a minimum GPA of 3.0 and must demonstrate an interest in health policy, regulations, or related healthcare fields.
- Location: Boston, MA
- Accreditation: New England Commission of Higher Education (NECHE)
- Format: Online
- Expected Time to Completion: 24 months
This online master’s program in regulatory affairs for drugs, biologics, and medical devices is designed to teach professionals how to navigate the complex regulatory landscape for innovative and cutting-edge products in science and medicine. The program fuses coursework with integrative, experiential learning so that graduates can deepen their knowledge of current regulations and the development and commercialization of drugs, biologics, and medical devices.
The program consists of 45 credits of core and elective courses and an integrative experiential learning or cooperative education program. Students can opt to concentrate on one of five unique concentrations: biopharmaceutical regulatory affairs, clinical research regulatory affairs, medical device regulatory affairs, nonclinical biomedical product regulation, or quality assurance and compliance. The number of electives students must complete varies according to concentration.
As part of the program, students will delve into topics such as introduction to regulatory compliance and practice, pharmaceutical and medical device law, introduction to safety sciences, regulatory strategy for product development and life-cycle management, and human experimentation: methodological issues fundamentals.
Admissions requirements include an undergraduate degree in pharmacy or life sciences (two to three years of work experience if the undergraduate degree is from another area), a completed online application, a statement of purpose, a current resume, two letters of recommendation, unofficial undergraduate transcripts, and proof of English language proficiency for students who did not have English as their primary language of education.
- Location: Boston, MA
- Accreditation: New England Commission of Higher Education (NECHE)
- Format: Online
- Expected Time to Completion: 12 to 18 months
This regulatory affairs and quality assurance graduate program at Temple’s School of Pharmacy is one of the oldest programs focusing on health regulations and quality assurance; the program was created more than 50 years ago. Temple’s instructors include industry experts and professionals with US FDA experience. This MS degree can be completed online or on-campus, and the school also offers 15 certificate programs, most of which can be completed online.
For the master’s program, students must take at least 36 credits, which includes four required courses and eight electives. The core topics cover drug development, food and drug law, ethical practices, and quality auditing. Students can take electives in regulatory affairs, quality assurance, medical devices, biotechnology and biosimilars, generic drugs, clinical trials, pharmacovigilance, and more.
No test scores are required for admission. However, students must have a bachelor’s degree with a minimum 3.0 GPA, preferably in a science or engineering field. Students without a science background may be required to take three prerequisite courses before applying.
Temple University also offers an online master of science program in pharmaceutical regulatory sciences and an online master of science program in global clinical and pharmacovigilance regulations, both of which require 30 credits to complete.
- Location: Philadelphia, PA
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Format: Online
- Expected Time to Completion: 36 months
UMGC offers an online biotechnology master’s degree specializing in biotechnology regulatory affairs. The program allows students to develop expertise in biotechnology regulatory affairs and the life cycle of biotechnology products. This online program includes a mix of challenging academic work, case studies, simulations, real-world experience, and a chance to work with mentors from the industry.
To graduate, students must complete 36 credits. Required and popular elective courses include bioprocessing and the biotechnology business, foundations of project management, biotechnology and the regulatory environment, and product lifecycle approval, production, and marketing. Students must also complete a capstone in biotechnology: regulatory affairs.
This program requires a bachelor’s degree in molecular biology. Students without these degrees must take college-level courses, including an introduction to molecular biology and societal issues in biotechnology, before the program’s start date.
- Location: Adelphi, MD
- Accreditation: Middle States Commission on Higher Education (MSCHE)
- Format: Online with hybrid options available
- Expected Time to Completion: 12 to 24 months
USC School of Pharmacy’s master’s program in regulatory science prepares students for in-demand careers as regulatory professionals both nationally and internationally. This program is designed for busy working professionals to pursue while working full-time. The school mixes intensive weekend classroom experiences with remote units, but the program is self-paced, and many of the lectures are available through the school’s distance learning program.
Students complete 36 credits: 25 credits of core courses and up to 10 credits of electives, which may include an internship. Curriculum topics include quality assurance for drugs and biologics, regulation of food and dietary supplements, regulation of medical devices & diagnostics, and the management and structure of clinical trials. Students with little to no industry experience are encouraged to pursue an internship as part of their elective coursework.
USC requires applicants to have a bachelor’s degree with an overall GPA of 3.0 or higher. Application requirements include two letters of recommendation, a current resume, and a personal statement that addresses your interest in the degree. Students who earned their bachelor’s degree from a non-English speaking country must submit proof of English language proficiency.
- Location: Los Angeles, CA
- Accreditation: Western Association of Schools and Colleges
- Format: Online or on-campus
- Expected Time to Completion: 24 to 36 months
University of North Carolina’s Eshelman School of Pharmacy offers an online master of professional science program in regulatory science that is recognized by the National Professional Science Master’s Association (NPSMA). The program provides students with balanced regulatory science and professional skills training and includes an internship experience that allows students to put all their skills to practice.
Applicants to the program must have a bachelor’s degree or its international equivalent from an accredited institution and a GPA of 3.0 or better. Preference will be given to applicants who hold bachelor’s or master’s degrees in engineering or life sciences and have relevant research or work experience.
The program comprises 32 credits and includes courses such as fundamentals of regulatory affairs, chemistry, manufacturing and controls, clinical development, biostatistics, emerging topics in regulatory science, regulatory communication, regulatory strategy, and applied project management.
- Location: Chapel Hill, NC
- Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
- Expected Time to Completion: Three to six semesters
Established in 1999, the Center for Regulatory Science at San Diego State University’s College of Sciences offers an online master of science program in regulatory affairs. Focusing on regulations, good manufacturing processes, and laws mandated by regulatory agencies, such as the FDA (Food and Drug Administration), the program helps students obtain advanced knowledge of current regulations. Students will further learn to apply this knowledge to developing and commercializing drugs, biologics, and medical device products.
The program consists of 37 credits and includes courses such as pharmaceutical, biotechnology, and medical device industries; food and drug law; medical & scientific writing for life science professionals; medical device regulations; investigational and marketing applications for drugs and biologics; international regulatory affairs; ethics for life science professionals; and effective communication for regulatory science.
- Location: San Diego, CA
- Accreditation: WASC Senior College and University Commission (WSCUC)
- Expected Time to Completion: 18 months
