“It catapulted me into my current senior management position in private industry,” says Helfgott, 34. “I was able to gain a foundation that allowed me to flourish in this industry.”
While still enrolled in the master’s program, he landed a fellowship at the Food and Drug Administration that led to several full-time positions at the agency. About a year ago, he became director of global regulatory affairs for medical device venture capital firm Stage 2 Innovations. In that role, he’s been involved with products like the NCP-5 External Counterpulsation device, which was recently cleared by the FDA for use in healthy patients to improve vasodilation and increase blood flow.
“Learning about the entire total product life cycle at the Johns Hopkins program really helped me to understand all the facets of product development and regulatory approval pathways, which I was ultimately able to leverage in obtaining our company’s recent clearance from the FDA on the NCP-5 ECP,” says Helfgott, who also teaches and advises students in Johns Hopkins’ regulatory science program. “It really is a multidisciplinary approach of being able to leverage scientific, technical knowledge with an understanding of the law.”
These days, it’s not enough to come up with a great idea for a product or medicine to help people suffering from various medical conditions. Understanding the steps necessary for gaining regulatory approval is crucial.
“Developing a new, FDA-regulated product is long, difficult and expensive,” says Daniela Drago, director of the regulatory affairs program at the George Washington University School of Medicine and Health Sciences. “If you want to save time and money, product development activities should be conducted in accordance with an effective regulatory strategy.”
That’s where master’s degrees in regulatory science come into play. These degrees help graduates learn to navigate the increasingly complex world of scientific regulations so they can help companies, universities, hospitals and scientific associations bring medical innovations to market. Through these programs, students like Helfgott who already have scientific backgrounds receive instruction on the regulatory process in general as well as how it relates to topics like product development, clinical trials, data collection and marketing.
“It’s a strong area to move into,” says Lynn Johnson Langer, director of the regulatory science and enterprise programs at the Center for Biotechnology Education at Johns Hopkins University. “There are lots of jobs from entry level all the way to C-level jobs, and they pay well.”
Georgetown University offers concentrations in regulatory science as part of its MS in clinical and translational research and MS in pharmacology degrees, and graduates of those programs have gone on to work for companies like 23andMe and Genentech.
“It takes decades to get a product to market,” says Erin E. Wilhelm, executive director of Georgetown’s program for regulatory science and medicine. “Part of that limitation is in science itself. But part of the reason why it takes so long is because you’ve got researchers doing specific types of research, but they’re not collecting the data that ultimately the FDA will need to see to determine whether the product is safe and effective.”
Folks with regulatory science degrees can help organizations ensure that research is being done with an eye toward requirements for regulatory approval, whether they’re the ones also doing the research or working as part of a larger team. “These programs take some of the murkiness out of what people perceive as the black box that is the FDA, the perception that data goes into the FDA but not a lot of information comes out,” Wilhelm says. “They break down some of those barriers.”
George Washington University developed its online MS in regulatory affairs program back in 2008 after realizing the need for more people with this training. The success of that program led this semester to the university’s launch of its new master of engineering degree program in regulatory biomedical engineering, which aims to educate engineers on the regulatory process to help bring new inventions to market faster.
“The regulatory affairs field is growing, and companies and government agencies are really struggling to find professionals with the right knowledge, skills and abilities,” Drago says. “Talented regulatory professionals don’t stay long on the job market.”
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