An International Approach

Global regulatory affairs course

Karl Burgin, Ph.D., has never been limited by geography. After earning a bachelor’s degree in biochemistry and a Ph.D. in neuroscience, the San Antonio, Texas, native stretched his wings, traveling across oceans as a drug development professional. Over the past two decades, his work in global regulatory affairs — he started in documentation before eventually moving up to strategic program management — has allowed him to cover a wide range of products with both small start-ups and large international pharma companies. Now, Burgin has added another location to his list: Washington, D.C. From his base in Basel, Switzerland, Burgin taught a section of Introduction to Global Regulatory Affairs at the GW School of Medicine and Health Sciences (SMHS) this past fall.

What led you to pursue a career in global regulatory affairs?

To be honest, I stumbled into it. I had finished a Ph.D. and didn’t know exactly what I wanted to do. I loved the intellectual side of research but felt I had done enough pipetting and plasmid preps to last a dozen life-times. [I was] living in Basel where, at that time, three of the world’s largest pharmaceutical companies were within half-a-mile of my door; it seemed like I should get into drug development. Once I got in, I found it to be a fascinating process. From my perspective, the great thing about getting into drug development was [that] I was able to apply my scientific background to advancing scientific knowledge without getting my hands dirty.

You’ve lived or worked in the U.S., the U.K., Germany, Switzerland, and Japan; what made you to pursue so many international opportunities?

Maybe just a bit of wanderlust. When I was in graduate school, I had an opportunity to participate in a one-year graduate exchange program with King’s College in London. As it turns out, I met my wife, Debbie, there. Then for my post-doc, I decided it would be a good idea to go back to Europe, partly so she would be able to see her friends and family in the U.K., even though we were in Switzerland.

I [also] had a chance to do some work with the U.S. Army in Germany. [Additionally,] while at Roche — this is jumping ahead — I had a two-year assignment with Chugai Pharmaceuticals in Japan, where I was facilitating all of the co-development projects between Roche and Chugai, Roche’s strategic partner. It was just a great opportunity.

What led you to become an adjunct professor at SMHS?

I had been working with the European Center for Pharmaceutical Medicine (ECPM) as an adjunct lecturer and examiner for their oral exams, and through that, I ran into Daniela Drago, program director for the Regulatory Affairs Program and for the Clinical and Translational Research Program SMHS. She and I worked together at Roche a number of years ago, but I hadn’t seen her in quite a while. She was at GW then; this was about a year ago. When I was doing one of the lectures at ECPM, she was visiting. We got to talking, and she invited me to participate.

Describe your experiences as an adjunct professor.

I was very impressed with the quality of the students at SMHS: their ability to interact, to ask interesting questions, and get interesting responses back. Even though sometimes the assignment had clear objectives, the things that different students would come up with to focus on often times were new for me. It was extremely educational for me. I learned a great deal from them and really enjoyed it tremendously.


The global regulatory affairs course, as part of the Regulatory Affairs or “RAFF” program, provides students with a framework necessary for developing an integrated understanding of regulatory affairs. With an emphasis on the big picture, the course covers U.S. and international legislation and regulatory processes guidelines, as well as the role that regulatory affairs leaders play in developing products, navigating the regulatory review and approval process, and contributing to keeping products on the market.