Online Master’s in Regulatory Science Programs – Medical Device, Food & Pharmaceutical Regulatory Affairs

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 regulatory science MS 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 the production of 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 is a 30 credits program including 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
• Estimated Tuition: Clinical research management – regulatory science ($857 per credit); MS in regulatory science ($857 per credit); MS in regulatory science – food safety ($857 per credit); corporate and healthcare compliance ($1,165 per credit)

George Washington University offers several graduate degree options relating to regulatory affairs. These programs include a master of science in health sciences (MSHS) program and a graduate certificate. Both programs can be completed entirely online with no on-campus residencies 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 regulatory affairs professionals 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 a medical field as well as 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)
• Estimated Tuition: $990 per credit

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 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 completing undergraduate courses in biochemistry and cell biology. Students without the courses above can take two prerequisite courses in bio-organic chemistry and the foundations in 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, preparing students for scientific, leadership, or administration positions such as food safety regulatory specialists, food safety consultants, food safety managers, and consumer safety officers.

This 40-credit program includes courses such as an introduction to food safety regulation; food microbiology; food labeling & packaging regulations; food toxicology; and food safety audits and surveillance. Students in this program 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
• Estimated Tuition: $5,008 per course

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 a total of 30 credits over two years, with two electives included in the curriculum. They study a range of 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
• Estimated Tuition: $1,060 per credit

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; and 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
• Estimated Tuition: $37,800 for the full program, but may vary according to concentration

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
• Estimated Tuition: Pennsylvania residents ($3,393 per course); non-residents ($4,218 per course)

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.

Students must complete 36 credits to graduate. 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 will have to 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
• Estimated Tuition: Maryland Resident ($514 per credit); out-of-state ($659 per credit)

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 ten 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
• Estimated Tuition: $2,137 per credit

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). Providing students with balanced regulatory science and professional skills training, the program includes an internship experience that will allow 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 with 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, along with relevant research or work experience.

Comprising 32 credits, the program 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 others.

• Location: Chapel Hill, NC
• Accreditation: Southern Association of Colleges and Schools Commission on Colleges (SACSCOC)
• Expected Time to Completion: Three to six semesters
• Estimated Tuition: Full-time (NC resident: $25,203; non-resident: $52,641); part-time (NC resident: $29,871; non-resident: $62,390)

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
• Estimated Tuition: $992 per credit