A Career Pivot
Tony Yang
Senior Regulatory Coordinator, Fred Hutchinson Cancer Center
When Tony Yang graduated from the University of Washington with a bachelor’s degree in microbiology, the Taiwan native thought he was headed for a career in a laboratory.
However, Tony’s first job in biotech exposed him to the quality assurance and regulatory side of the industry, and he was intrigued as he learned about what it takes to bring new medical products, devices and biologics to market.
As he looked into how he could transition into this area of the industry, Tony’s research led him back to the UW and the Master of Science in Biomedical Regulatory Affairs (BRAMS) program.
“I was looking to diversify my experience and build my professional credibility in the regulatory field,” Tony said. “The BRAMS program turned out to be a great way to meet both goals.”
In this interview, the 2020 graduate discusses how this master’s degree program gave him the depth of knowledge and connections in the industry he needed to launch his career in biomedical regulatory affairs, and why it’s a great time to work in this field.
Tell us about your current job.
I currently work at Fred Hutchinson Cancer Center as a senior regulatory coordinator. In my job I work with various study teams on the preparation, submission, and maintenance of their Investigational New Drugs (INDs). After facilitating a study team’s initial IND submission to the Food and Drug Administration (FDA), I continue to monitor the submission and provide support for amendments, requests for more information, or withdrawals. With an FDA-approved IND, researchers can administer their investigational drug to humans in a clinical study and potentially generate data to support the product’s commercialization.
Fred Hutch is an amazing place. It’s the biggest cancer research center around, and I’m really grateful to be part of their mission. And a lot of people at Fred Hutch know about the BRAMS program. So, I found it easy to network and find a role there.
Why is this a good field to go into right now?
Seattle is a growing hub for biotech startups, so I think there will always be companies here looking for regulatory affairs professionals. There will always be new products coming onto the market, or existing products that need to be maintained, and companies need professionals who know how to help with that process.
You can have a promising team with a stellar product, but if you don't know what you're doing, the chances are good that your product will get rejected by the FDA. And you're going to lose out on getting it to market. So, you need someone who knows how to talk to the regulatory agencies, submit the right applications, and address potential safety risks.
How did what you learned in the program set you up for success in your career?
This program doesn’t teach you to memorize the code of federal regulations. It teaches you how to gather information, how to address potential problems with new drugs and devices by thinking critically, and also how to work with others. In addition, the program helped me become a better writer, which is a key skill in this industry.
While studying in the program, I had the opportunity to be an Institutional Review Board member at Bastyr University. By serving on that review board, I gained a deeper understanding of the potential safety and ethical ramifications of unthoughtful study protocols.
Then, I completed my practicum project as a quality assurance/regulatory affairs intern at NanoString Technologies, which gave me insight into supplier quality, customer complaints handling, and what comprises a proper 510(k), a premarket submission that clears a product for marketing based on substantial equivalence to an existing product on the market.
Another great thing about the program was that each written assignment or group project I worked on added to my portfolio — a collection of work samples that I could use to showcase my experience during job interviews.
What were some of your favorite courses and instructors?
Dave Hammond is the instructor who made the biggest impression on me. He taught the Introduction to Clinical Trials series and the International Regulatory Affairs course, and was really open to sharing his experiences as a consultant in the industry. He gave examples of why these regulations exist and was able to show us the pain points of being a regulatory professional in a real-world work setting.
What would you tell others who are considering applying to the BRAMS program?
I highly recommend it. My master’s degree gave me all the expertise and confidence I needed to work in the biomedical regulatory field. I had the support of my peers and instructors, and thanks to all of the opportunities I had to learn and network during the program, I’ve become a more versatile regulatory professional.
— Interview by David Hirning, January 2025