Faculty Profile: Karen Zhou

Faculty Profile: Karen Zhou

Karen Zhou was recently appointed as the new full-time Assistant Teaching Professor for the Regulatory Affairs program at Northeastern University in Toronto. We sat down with Karen to find out what brought her to Northeastern and what makes the program she teaches special.

Could you tell us about your background and what led you to Northeastern?

I was a molecular biologist and biochemist by training, and after that I transitioned to law school. Professionally, I started out working in government before deciding to pursue an opportunity in industry. I eventually found myself working in the medical technology sector advising on regulatory and compliance issues. I have worked within organizations of all sizes from start-ups to larger international organizations. Each experience offered a new perspective and introduced a different business model and how regulatory affairs fits into this framework.

Through these diverse roles I developed skills and knowledge on every aspect of the product lifecycle from premarket to postmarket compliance. I have also been able to rely on and leverage my legal training and background to interpret statutes and regulations effectively and guide organizations through the more “grey” areas of regulations. It is the “grey” areas of regulatory affairs that makes it such an interesting profession.

In early 2020, I saw a posting for a part-time lecturer in Regulatory Affairs at Northeastern and decided to apply. Through online teaching and the transition to in-person classes I have enjoyed working with an international community of learners. In 2022, when a full-time opportunity came up at the Northeastern Toronto campus, I thought it was perfect as I had the theoretical and practical knowledge as well as the teaching experience to boot. My interdisciplinary background has also been helpful in providing new perspectives on the profession.

What are some of the unique advantages of the Regulatory Affairs program at Northeastern?

Regulatory affairs is a profession that draws on many skills and educational backgrounds. The health care industry, which includes both pharma and medical devices, has a demand for skilled regulatory professionals with the technical know-how and a strong business acumen. To that end, Northeastern has an array of course offerings that take the students from the technical fundamentals to understanding the bigger picture through courses on regulatory strategy and legal issues.

The MS Regulatory Affairs at Northeastern is global in scope, covering a wide range of jurisdictions. We are also conscious to blend theory with practical experience so that students are exposed to “real-life” in the sector. This extends to the instructors who bring their own experiences from industry to give students a real sense of what a career in regulatory affairs is like.

Another strength of the program is the diversity of its curriculum. Students can pick from multiple concentrations, from compliance to pharmaceutical or medical device regulatory affairs. There is so much to choose from, and this empowers students to make choices that suit them.

How are you preparing students for emerging challenges in the sector?

The ability to communicate well and understand the business environment is crucial. Strong communication skills are an important complement to regulatory knowledge, especially with an international student body that will be working across cultures for their entire careers. Communication competency goes hand in hand with building resilience and the capacity for adaptability in an unpredictable and changing global environment.

What are the benefits of being in Toronto for Regulatory Affairs students?

We’re very lucky to be in Southern Ontario, which has a reputation in Canada as a hub for pharmaceuticals and medical technology. There are many multinational companies located here as well of a range of medical technology start-ups. This makes for a very vibrant environment that creates lots of opportunities for regulatory affairs professionals.

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