Kristen Biernat graduated from UNC in 2018 with a Ph.D. in Chemistry. She was interviewed by Taylor Enrico in Sept. 3, 2020 when she was a Regulatory Scientist at CATO SMS.
How do you define regulatory affairs?
It is an industry that oversees how drugs and medical devices are developed and manufactured so that they are safe for human use.
What does your current job entail day-to-day?
I’m a Regulatory Scientist at CATO SMS, and we provide regulatory and scientific guidance on drug development issues. My job involves a lot of different responsibilities including writing regulatory clinical documents, like safety reports, pre-IND [Investigational New Drug] packages, and informed consent forms and protocols. I also help manage regulatory submissions to the FDA.
Can you tell me a bit about your career path and how you found your current position?
About halfway through grad school, I started to realize that bench science was not for me, so I began researching careers that did not involve benchwork. I became interested in regulatory affairs, because I read that it involves a lot of project management and medical writing, and those were the types of things that I enjoyed during my PhD. I was able to get a [TIBBS ImPACT] internship at CATO SMS during graduate school that I really enjoyed. So, I applied for CATO SMS’s fellowship program, and I was lucky enough to be accepted. After one year in the fellowship program, I was offered a fulltime position as a Regulatory Scientist.
What was the process of getting your Regulatory Affairs Certification (RAC)?
At CATO SMS, everyone that was interested in taking the RAC exam met once a week to go over a couple of chapters in the RAC textbook. I also independently read the textbook and sought out online resources on the topics in the book. I started preparing 3-4 months before the exam. I took the U.S. exam, which covered both drugs and device regulation for the U.S., but now the exam format has been changed. There is no longer a U.S. exam; there is a drug exam or a device exam, and those cover regulations in the United States and Europe.
What excites you the most about your work?
I am doing something new every day and I am working with novel drugs. At the end of the day, it is nice to know that my work may end up helping someone and improving lives.
How did GBCC help you launch your career?
I was one of the coordinators for the Beyond the Bench Seminar Series. One of the first speakers we invited worked in the regulatory affairs field, which got me interested in the career. The Beyond the Bench series also allowed me to explore other careers, identify what I could potentially see myself doing, and what I thought I might not enjoy doing, which really helped me to pinpoint what I wanted to do.
What is one piece of general advice you would offer to current GBCC members?
Talk to as many people as you can about their careers. It will help you determine whether their career might be a good fit for you and will help you to build relationships with people in the workforce.
What do you think is the best way to network?
I would search for jobs on LinkedIn that I am interested in pursuing to find people to talk to. If I have a mutual connection, I might ask my mutual connection to introduce me. If I didn’t have a mutual connection, then I would cold message the person. Most people are very willing to talk about their career.
What advice would you offer to students interested in pursuing a career in regulatory affairs?
I would try to use all of the resources that you can find to learn more about regulatory affairs. I know that Duke offers a regulatory affairs class; I took that. I would also recommend going to seminars where someone who works in the regulatory field is presenting. And I would reach out to people working in the field and talk to them about their career.
Thanks to Kristen for spending time with us to learn more about her experiences! If you’re interested in following her footsteps, you can visit the website of the GBCC as well as Duke’s Regulatory Affairs Training program that she mentioned. You could also reach out to her via LinkedIn.