Online Master’s in Regulatory Science and Affairs Degree Programs
Navigating the regulatory environment in the pharmaceutical and medical device industries is a complex and challenging process. The development and sale of prescription drugs, biologics, and biotechnology products is subject to strict federal oversight by the Food and Drug Administration (FDA), the primary agency tasked with ensuring safety and quality. Research and development in this area of the healthcare sector must also adhere to state laws and industry standards for good laboratory practices (GLPs), good clinical practices (GCPs), and good manufacturing processes (GMPs). In order to manage compliance issues and successfully bring new drugs and therapeutics to market, biotech firms and pharmaceutical companies rely on professionals with specialized knowledge and skills in regulatory science and affairs. Working in this field requires knowledge of FDA policies, medical research procedures, and bioethical guidelines, as well as familiarity with the economics of the pharmaceutical and medical device industries.
What Is a Master’s in Regulatory Science and Affairs Degree?
A master’s in regulatory science is typically a Master of Science (MS) degree program that provides integrated, interdisciplinary training and instruction in technical, scientific, legal, and economic aspects of the drug and medical device industries. These programs are designed to prepare students for the challenges of bringing therapeutic products to market, through the different phases of clinical trials, peer review and FDA approval processes, and the quality control and assurance audits that apply to prescription and over-the-counter drugs, vaccines, and medical devices. Students in these master’s programs learn the business side and regulatory imperatives of this industry at the state, federal, and international levels. They also cultivate technical writing and oral presentation skills for communicating research findings, and develop proficiencies in areas of data management and analysis relevant to medical regulatory and compliance requirements.
Online Master’s in Regulatory Science and Affairs Programs
Online master’s programs in regulatory affairs offer students interested in pursuing a career in this field with a more convenient and flexible alternative to traditional, campus-based programs. Students in an online program receive all or most of their instruction through distance learning technologies, which facilitate the online delivery of lectures and other course materials. By logging on to a learning management system (LMS), students are able to attend classes in a virtual environment, complete assignments, participate in discussion forums, and contact instructors via email and other modes of electronic communication. All or most of the instruction in these programs is provided online, as are supplemental educational resources, such as access to a school’s library.
How OnlineEducation.com Identifies and Classifies Online Master’s in Regulatory Science and Affairs Programs
OnlineEducation.com researches online programs and identifies master’s programs that offer training in regulatory science and affairs. These programs have a number of different designations, including:
- Master of Science in Regulatory Science
- Master of Science in Regulatory Affairs
- Master of Science in Health Sciences in Regulatory Affairs
- Master of Science in Regulatory Affairs and Quality Assurance
- Master of Science in Pharmacy with a specialization in International Biomedical Regulatory Sciences
In addition to researching curricula, OnlineEducation.com ensures that programs on the site are offered by regionally accredited, non-profit colleges and universities, and that they offer all or most of their coursework online. Programs that require students to attend more than two on-campus sessions per year are not included on the site.
What Students Learn in an Online Master’s in Regulatory Science and Affairs Programs
There are several components of a master’s curriculum in regulator science and affairs. Students takes courses that provide a grounding in the fundamentals of medical research, including the bioethical concerns, legal constraints, and best practices for preclinical investigations and clinical trials involving human subjects. They study FDA regulations, international governance of standards for drugs and medical devices, and the function of institutional IRBs (internal review boards) and other oversight committees. And they learn about the pharmaceutical, biotechnology, and medical device industries. These areas of knowledge are then integrated into a strategic approach to managing the relationships between regulatory issues and business objectives, technical and non-technical staff, and internal and external control mechanisms. Many online programs include a formal capstone project that challenges students to apply what they have learned in the program to real-world issues in regulatory science and affairs.
Online Master’s in Regulatory Science and Affairs Program Courses
The table below offers an overview of typical coursework in a master’s in regulatory science degree curriculum. The names and descriptions of the courses listed below are adapted from actual online master’s programs.
|Course Title||Course Description|
|Introduction to Regulatory Affairs||An overview of the history of regulation in the drug industry, with a focus on various regulatory agencies, access to regulatory information, and the submission and approval processes for pharmaceuticals, biologics, and medical devices.|
|Biological Processes in Regulatory Affairs||An examination of the laboratory techniques used in the discovery, evaluation, and development of therapeutic pharmaceuticals and biologics, including gene cloning, recombinant DNA processes, protein purification, and immunoassays.|
|Regulatory Strategies in the Development of Drugs & Biologics||An analysis of critical elements of the product life cycle in the determination of a regulatory strategy, the roles of non-clinical and clinical data in determining regulatory strategy, and approaches for integrating strategic business needs into regulatory planning.|
|Regulatory Strategies in the Development of Devices & Diagnostics||An analysis of the principle components of global regulatory strategy for devices and diagnostics, including an examination of the regulation of medical devices through an epidemiological lens and of the considerations associated with different classifications for medical devices.|
|Introduction to CGMP Compliance||An overview of Current Good Manufacturing Practice (CGMP) regulations enforced by the FDA to assure proper design, monitoring, and control of manufacturing processes and facilities for the production of human pharmaceuticals.|
|Food & Drug Law||An examination of the Food, Drug, and Cosmetic Act (FD&C Act) and its governance of the regulatory approval process for bringing a drug, biologic, medical device, food, or cosmetic to market, as well as the enforcement activities of the FDA, including inspections and audits, seizure actions, injunctions, and criminal prosecutions.|
|Bioethics||The application of ethical frameworks to critical issues and selected cases involving experiments with human subjects, organ transplantation, in-vitro fertilization, the use of animals in research, the collection and publication of research data, peer review, conflicts of interest, and other topics of current concern.|
|Bioscience Communication||Strategies and skills for communicating scientific findings verbally and in writing with researchers, administrators, investors, and regulators.|
|Clinical Research Data Management & Technology Implementation||Database design and management in clinical research, with a focus on privacy and other compliance issues, data auditing, and procedures for continuous quality improvement (CQI) in clinical research.|
|Translational Biotechnology: From Intellectual Property to Licensing||An overview biotech and pharmaceutical research and development from the perspective of patents, intellectual property laws, licensing agreements, and other legal issues that may be relevant in communications between regulatory compliance officers and the FDA.|
|Leadership & Change in Regulatory Affairs||A capstone course integrating scientific knowledge, business proficiencies, and organizational skills into a plan for leading change within the context of health professionals, health systems, and health policy.|
Admissions to Online Master’s in Regulatory Affairs Programs
Admissions policies and criteria vary by school and by program. However, the basic requirement for admissions to a master’s level degree in regulatory science and affairs is a bachelor’s degree from an accredited college or university. While it is often helpful for applicants to have a background in the life sciences or engineering, most programs admit candidates who have completed certain undergraduate prerequisites. These may include biochemistry, cell biology, anatomy, physiology, and/or health science courses. Programs may waive these prerequisites for applicants who have one or more years of experience working in healthcare. In additional to college transcripts, online programs may require students to submit GRE scores, two or more letters of recommendation, and/or a written statement of purpose. Selective online programs typically prefer candidates who have a cumulative grade point average (GPA) of 3.0 or higher from their undergraduate studies, although this requirement may be waived for applicants who have relevant professional experience or an advanced degree.
Online Master’s in Regulatory Science and Affairs Program Formats
Online master’s in regulatory science programs are generally designed to be flexible and convenient enough to accommodate students who may be working full-time or have other commitments outside of school. These programs are often ideal for those who want master’s level training in regulatory science without having to relocate or commute to earn their degree. However, there are several important variations in formatting and structure that can impact the relative convenience and flexibility of an online program. These include: synchronous vs. asynchronous instruction; part-time vs. full-time enrollment; and whether or not the program requires students to attend on-campus sessions.
Synchronous vs. Asynchronous Instruction: The two primary methods of online instruction are synchronous and asynchronous instruction. Courses that require students to be logged on to the school’s LMS at designated times in order to view lectures and participate in instructional activities utilize what is known as synchronous instruction. Online courses that do not have set meeting times and that allow students to access lectures at their convenience utilize asynchronous instruction. While asynchronous instruction offers more flexibility, it provides less structure than synchronous instruction. Students who prefer an online program with a more structured learning environment may favor synchronous instruction. For self-motivated students who anticipate potential scheduling conflicts, asynchronous instruction may be a better option.
Part-Time vs. Full-Time Enrollment: A typical master’s in regulatory science program can be completed in four semesters, or roughly two years, of full-time enrollment by students who take three or four courses per semester. Students who attend a summer session may be able to graduate in as few as 20 months of full-time enrollment. Applicants who are aiming to get their degree in two years or less should look for full-time programs. There are also programs that offer a range of part-time enrollment options for students who would prefer to take fewer courses per semester. These programs take longer to complete, although part-time students who take courses over the summer may still be able to graduate in two years. Many online programs offer students a choice of part-time and full-time enrollment options, although some may only offer one or the other.
Campus Visits: Many of the master’s in regulatory affairs programs on the site are offered 100% online, which means that students do not have to visit the school’s campus in order to earn their degree. However, some online programs include a limited number of required campus visits for orientation and instructional purposes. On-campus sessions, which typically do not last more than a week, can add a useful face-to-face component to an online program. However, students may incur travel and lodging expenses while attending these sessions, and they may cause scheduling problems for those who are working while earning their degree. OnlineEducation.com does not currently include programs that require more than two campus visits per year.