Online Master Of Science In Regulatory Affairs

Last Updated on December 20, 2022

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A master’s degree in regulatory science (also called regulatory affairs) can prepare students for a career helping biotechnology, bioscience (including food science), and biomedical engineering (medical device) companies navigate the complicated legal and regulatory aspects of healthcare. Because regulations are continually changing, this field is both emergent and dynamic.

Emerging Trends in Regulatory Affairs in 2020 | Northeastern ...

Compliance with state and federal laws is essential to biotechnology and biomedical companies. Additionally, as biotech and biomed companies expand internationally, they can expect to come across new global compliance rules and regulations as well. 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 new pharmaceuticals, food products, medical devices, and medical processes throughout the development, approval, and compliance phases. These programs may 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.

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 eight online programs specializing in health product regulation and three outstanding educators leading these programs.

Arizona State UniversityClinical Research Management – Regulatory Science (MS)View Full Profile
Arizona State UniversityCorporate and Health Care Compliance (MLS)View Full Profile
Johns Hopkins University – Advanced Academic ProgramsMS Food Safety RegulationView Full Profile
Johns Hopkins University – Advanced Academic ProgramsMS Regulatory ScienceView Full Profile
The George Washington University School of Medicine & Health SciencesMSHS in Regulatory AffairsView Full Profile
Pharmaceutical Science / with Management Studies Masters (MSc ...

Featured Online Regulatory Science & Affairs Programs

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.

1Johns Hopkins UniversityView Full Profile

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 core courses on enterprise and regulatory affairs and three electives in advanced topics in the regulatory approval process of global and national biotech products. Coursework includes bioethics, managing and leading biotechnology professionals, international regulatory affairs, and preparing a successful submission. Professionals teach the 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 the completion of undergraduate courses in biochemistry and cell biology. For students without the courses above, they 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.

  • Location: Rockville, Maryland
  • Accreditation: Middle States Commission on Higher Education
  • Format: Online
  • Tuition: $1,049 cost per credit
  • Program length: Two years

2George Washington UniversityView Full Profile

George Washington University offers several graduate degree options relating to regulatory affairs. These programs include a master’s of science in health sciences (MSHS), a graduate certificate, and a healthcare MBA with a graduate certificate. 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 in the field. The coursework was developed in collaboration with regulatory affairs professionals and governmental agencies, including the FDA. Program courses include issues and trends in health systems, clinical research for regulatory affairs, and regulatory strategies courses.

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.

  • Location: Washington DC
  • Accreditation: Higher Learning Commission
  • Format: Online
  • Tuition: $895 cost per credit
  • Program length: Two years

3Arizona State UniversityView Full Profile

ASU’s clinical research management master’s program with a concentration in regulatory science prepares candidates for expanding roles 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 natural sciences managers, soil and plant scientists, and agricultural and food science technicians. 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 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 work or internship experience in clinical research.

  • Location: Tempe, Arizona
  • Accreditation: American Association of Colleges of Nursing (CCNE)
  • Format: Online
  • Tuition: $512 cost per credit
  • Program length: Two years

4University of Southern California

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 drug and biologics regulation, regulation of food and dietary supplements, quality assurance, 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. They also require GRE scores of 153 Quantitative and 144 Verbal.

  • Location: Los Angeles, California
  • Accreditation: Western Association of Schools and Colleges
  • Format: Online or on-campus
  • Tuition: $1,830 per credit
  • Program length: 18 months

5Northeastern University

The Northeastern University 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 as well an integrative experiential learning or cooperative education program. Students can opt to concentrate in general, international, or operational regulatory affairs, as well as clinical research, medical devices, strategy, or regulatory compliance. The number of electives students must complete varies according to concentration.

Admissions requirements vary according to concentration. For example, for the strategic regulatory affairs track, students must have at least three to four years of experience in a regulatory affairs position.

  • Location: Boston, Massachusetts
  • Accreditation: New England Association of Schools and Colleges
  • Format: Online
  • Tuition: $31,095 for the full program, but may vary according to concentration
  • Program length: One to two years

6Massachusetts College of Pharmacy and Health Sciences

MCPHS offers an online master of science in regulatory affairs and health policy. The school’s goal is 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 semesters, with one elective each term. 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, Massachusetts
  • Accreditation: New England Association of Schools and Colleges
  • Format: Online
  • Tuition: $930 per credit
  • Program length: Two years

7Temple University

The 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 12 certificate programs, most of which can be completed online.

For the master’s program, students must take at least 36 credits in pharmaceutical regulatory affairs and quality assurance, 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 sciences or engineering field. Students without a science background may be required to take three prerequisite courses before applying.

  • Location: Fort Washington, Pennsylvania
  • Accreditation: Middle States Commission on Higher Education
  • Format: Online
  • Tuition: $1,350 per credit
  • Program length: Three years

8University of Maryland Global Campus

UMGC offers an online biotechnology master’s degree with a specialization 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 business of biotechnology, foundations of project management, biotechnology and the regulatory environment, and product lifecycle approval, production, and marketing. Students must also complete a Capstone in biotechnology.

This program requires a bachelor’s degree in molecular biology. Students without this degrees will have to take college-level courses, which include an introduction to molecular biology and societal issues in biotechnology, ahead of the program’s start date.

  • Location: Largo, Maryland
  • Accreditation: Middle States Commission on Higher Education (MSCHE)
  • Format: Online with hybrid options available
  • Tuition: $659 per credit
  • Program length: One to two years

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