Chemist Gains Practical Skills in Regulatory Affairs Program


- Denise Andersen

Term : November, 2014
Department : Biosciences
Program : Regulatory Affairs

Back in 2012, Denise Andersen, a professional chemist, noticed a demand for skilled professionals in regulatory affairs. An experienced Ph.D. in chemistry, she turned to UCSC Extension’s Regulatory Affairs program to expand her understanding of biologics, pharmaceuticals and devices. She appreciated Extension’s hands-on, practical approach to regulatory affairs, and since completing the certificate, has used her new skills to prepare a new drug application (NDA) for the FDA.

Which Extension courses stood out to you?

I really liked the “Regulatory Submissions: Devices and Diagnostics” class. The instructor assigned us a fake device and we had to try to modify it, propose all the tests, make sure it’s safe, explain how you would design it, and what materials you’d need. “Regulatory Submissions: Drugs and Biologics” was similar in that you took a drug that had been approved and had to reverse-engineer it, thinking about what steps the company took to get it approved. I worked with 10 people and we each wrote a different piece of the plan. I liked the courses that were practical and focused on what applies to you and what you would have to do if you were working in regulatory affairs. I already had the [scientific] vocabulary; I wanted to learn how to apply what I was learning.     

What were your instructors like?

One of the reasons I enrolled was to expand my networking base—which the program did, through my instructors and colleagues who were taking courses at the same time. I got a lot from the instructors, who would share as much as they could about their professional experience. They were very approachable.

What kind of community did you find at UCSC Extension?

My classes were pretty diverse. I’d say about half my classmates were working in devices, the other half in drugs. When I first started [in 2012], I noticed that there were a lot of us seeking new work opportunities. By the time I finished the program [in summer 2014], most of my classmates or people I was in the program with were employed.

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