The Mindset Needed for Developing Global Leaders in Regulatory Affairs


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How do you cover the wide swath of expertise needed in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices program? You find a leader, who has broad experience in diverse life sciences areas and a professor who can teach the applicable skills and has the specific understanding of what is required to bring products to market in global and highly regulated environments. With Dr. Stephen Amato, the Quality Assurance and Advanced Manufacturing Domain leader, you have the "scholar/practitioner" who has extensive global experience in these vastly different arenas. He teaches classes such as "Therapeutics Product Development" and "Emerging Product Categories in the Regulation of Drugs and Biologics" and writes scholarly articles with his students on specific industry and healthcare topics.

This unique graduate degree program (taught online and on campus in Boston and Toronto) helps meet the increasing demand for regulatory affairs professionals who understand the complex processes involved in the discovery and commercialization of new biopharmaceutical and medical device products.  Students learn during their course of study the series of steps required to bring new medical products to market in the United States and globally, which is tightly regulated and must be practiced in order to master.

As an illustration, governmental regulatory requirements may differ substantially by geography. One such example is the focus in the United States on cybersecurity, and the regulation of digital health technologies by the US Food and Drug Administration. There are substantial policy differences between the US, European Union, Japan, and Canada in this area. The result is that manufacturers must design their medical products in different ways in order to meet cybersecurity standards established by regulators in specific geographies of interest. Such manufacturers depend heavily upon regulatory affairs practitioners in their organizations and it is critical that these practitioners understand and maintain currency with evolving cybersecurity standards.

"Regulatory affairs professionals are responsible for evaluating the efficacy of new types of products and determining what populations are best suited to receive them in the clinic. They are also responsible for assessing the safety of their use in these populations, identifying the potential risks involved, and developing strategies to mitigate these risks," said Dr. Amato in a profile on the Northeastern Toronto website.

A growing percentage of the students in the program work outside of the United States for companies that have a global manufacturing footprint and are seeking international marketing rights. For these students, there are specialized courses in the Regulatory Affairs program such as "Biomedical Product Regulatory Affairs in Emerging Markets: Russia and Kazakhstan" and "Working in Multicultural Environments: Challenges and Opportunities." 
These classes focus on diverse geographic areas so students can gain a practical understanding of the associated regulatory processes, and the specific types of obstacles that companies may face in these geographies, as well as how to overcome them. Also, according to the description of the "Multicultural Environments" class, the class provides "a general overview of and guidelines for working in multicultural teams with particular reference to the pharmaceutical industry and ... the challenges and opportunities of various cultural models." 

Approximately 40 percent of the students in the program are currently working in regulatory affairs: after receiving their degree, they continue at their current organizations or companies; others go to startups and some join pharmaceutical companies such as Vertex Pharmaceuticals, Smith & Nephew, Stryker Endoscopy, Takeda, GlaxoSmithKline, and Amgen.