This article provides some insight into the masters in regulatory science degree program, some of the subjects and courses that are included, and why this degree could be a good career move. It will also present an online program for a masters in regulatory science that you might want to consider.
What Is a Masters in Regulatory Science?
The field of regulatory science is relatively new, in as such that it has only recently grabbed the attention of schools and universities. It is believed that regulatory scientists will soon be required to hold a doctoral degree in this field, and many schools have started to offer such programs. At present, the masters in regulatory science is both an art and a science, in which graduates learn to take new food and medical products on the market, and keeping them there, while meeting the various legal and federal requirements. Essentially, it means that graduates conduct studies, but within a legal framework.
The science is incredibly broad, as are the responsibilities of those who have completed the degree. It requires you to have a solid understanding and grasp of the continuum of drug and food-development processes, and also the research and regulations that are involved. You will learn all there is to know about regulatory affairs, risk management, regulatory writing, regulatory law, and regulatory compliance. It is a discipline that is closely related to the biomedical field, such that biomedical scientists will create new products while regulatory scientists ensure that these products are compliant with laws and regulations.
Graduates will take part in preclinical studies, research and development, the manufacturing process, clinical studies, marketing, post-marketing research, and more. All of those elements have to meet specific regulations and laws, and it will be your responsibility to make sure that they do. Some regulatory scientists focus on just one of these elements, whereas others work across the continuum. This mainly depends on where you have obtained your degree, and whether the school allows specializations in a specific field in relation to drug and food development. Overall, you will be responsible for the evaluation of clinical trials and its candidates, rather than running them. You will also be a mediator between the different parties involved in clinical trials and product development, aiming to reach a consensus through compromise and negotiation.
The field is interesting for people from a variety of backgrounds, including engineers, chemists, life scientists, and physicists. Unsurprisingly, there are strong links between regulatory scientists and the FDA (U.S. Food and Drug Administration), and they have jobs for regulatory scientists in over 30 different disciplines. These include clinical medicine, nursing, veterinary medicine, statistics, pharmacy, and research science.
Why Earn a Masters in Regulatory Science?
The U.S. Department of Health and Human Services recently announced a new collaboration between the NIH (National Institutes of Health) and the FDA where some $6.75 million will be awarded for research projects that develop new models, methods, and/or technologies that will assist in evaluating the efficacy and safety of new medical products. This presents a huge opportunity for graduates to take up positions with the FDA, and also with companies that develop biomedical devices and products. They all have a requirement for biomedical scientists to ensure that all guidelines and regulations are being met. There is also an international focus, because many products are delivered in other countries, where different regulations are in place. Masters in regulatory science degree holders, therefore, are in high demand as consultants in the international market as well.
According to a Payscale report in July 2016, those with a masters in regulatory science can expect to earn $63,000 per year on average. That said, the key reason why people choose to complete a masters in regulatory science is not because of the potential high earnings. Rather, it is because they can take on a position of leadership in a field that has a positive impact on the lives of practically every person on earth. They hold responsibility for ensuring that everyday products are safe and effective. For most, the personal satisfaction that this brings is more important than any salary, no matter how high it is.
Online Option for Masters in Regulatory Science
Johns Hopkins University
The Krieger School of Arts and Sciences of Johns Hopkins University offers a highly respected online program for obtaining a masters of regulatory science. This program has been developed to meet the increasing demand for experts who understand compliance with state and federal regulations, and how this ensures biotech companies can survive. Biotech companies have reported a strong demand for these professionals, and institutions like Johns Hopkins University are responding.
The aim of the program is to help people enter a career in regulatory science, emphasizing regulatory approval topics on domestic and global biotech products in particular. There are three elective directions to take:
- Health sciences
- Laboratories
- Enterprise and regulatory affairs
Regardless of the concentration chosen, students will be provided with both classroom and hands on training on issues covering clinical, laboratory, and manufacturing processes, as well as product development. Furthermore, graduates from the program can take advantage of network of employers that work with Johns Hopkins University. Thus, a job is almost guaranteed.
Students have to take part in 10 courses, seven of which are part of the core curriculum. During the program, students will take part in scientific experiences through various case studies, as well as through a final practicum. Graduates are respected for their skills in research, evaluation, and presentation of legally justifiable scientific positions.
The program is delivered online and is targeted at those who are employed. Some of the courses can be completed on campus in Rockville, MD, and they are offered on weekends or during the evening. The courses, while online, are highly interactive and are delivered by professionals in the biotech industry, the FDA, and other similar organizations. The program must be completed in five years, although most students are able to finish it in two years.
The core curriculum includes:
- Bio-Organic Chemistry
- Foundations in Bioscience
- Biochemistry
- Molecular Biology
- Advanced Cell Biology
Students will then have to complete courses from their chosen concentration area, as well as science elective courses.
Some careers that you could have once you complete a masters in regulatory science are:
- Regulatory affairs specialist
- Clinical trial data analyst
Summary
By completing a masters in regulatory science, you will have skills and knowledge that are in high demand and that will enable you to greatly advance your career. There is a significant shortage of experts who understand regulatory science and universities like Johns Hopkins are even working together with employers to ensure that graduates are snapped up straight away. This is a great degree to tremendously advance your career and set yourself up as a leader and expert in your field.
References
- Master of Science (MS), Regulatory Science Degree Average. (2016, Jul. 31). Retrieved from http://www.payscale.com/research/US/Degree=Master_of_Science_(MS)%2C_Regulatory_Science/Salary
- Regulatory Science. (n.d.). Retrieved from http://advanced.jhu.edu/academics/graduate-degree-programs/regulatory-science/
