How Janine Best tamed the many acronyms and fuzzy words in regulatory affairs
Janine Best is a senior associate, global regulatory affairs with MIMEDX who is pursuing a Master's in regulatory science at Johns Hopkins University and has been a RAPS member since 2020. She shared her early career journey, how to combat misinformation, the role advertising and promotion play in regulatory affairs, and the remedies for an acronym-heavy industry when we connected with her at RAPS Convergence 2022. This conversation has been lightly edited for clarity.
How did you get started in regulatory?
I worked in a processing lab and manufacturing, and then I worked in quality control. Honestly, it was a coincidence because I was talking to a person at another company in clinical and I was stressing that I liked working in the lab, but I didn’t want to be stuck on the bench all day. I think I’m too much of a people person to sit in front of a hood all day. So, I wanted a job where I could actually apply the science, but at the same time be able to communicate with people. And take that information and communicate it in different forums and trainings, and also in writing. So, when I said that to the person at the other company, they said, you should look into regulatory affairs. I just put it in the back of my mind. And, honestly, I didn’t even know what it was. And, then a few months later a job popped up at my company—an entry-level job in regulatory affairs. I applied for it and got it. At that time, I didn’t know a lot about regulatory affairs. However, a lot of what I was doing in quality and my experience in the lab was helpful as far as the CMC portion of what they were working on. I was also able to work in promotion and advertising as well. So, it was purely accidental.
What do you like about regulatory affairs?
I like taking complex ideas and translating them into something that everyone can understand at my company. Also, being in the advertising and promotional space, a lot of what comes from our clinical research and non-clinical research gets translated into information that goes into advertising. And the ability to make that information more palatable to people and create information that can be shared in different venues like advertising or a brochure—I like that idea. It’s a challenge working in ad promo because the scientific research doesn’t always translate into fuzzy words you can put up on a banner. That’s been the most interesting part for me. You’re the liaison between what the laws are saying and what needs to be executed for the customer.
Why is professional development so important in regulatory affairs?
I have to keep learning. When I first started working in regulatory affairs, I didn’t know a lot about it. It was death by acronym. There were so many acronyms I didn’t know. And every day a new one comes out and I just feel like there is a need to keep developing myself. I feel like a lot of things I want to do don’t even exist at my company. I work with a very small company. I was the fourth person to join our regulatory team and now we’re up to eight people. And my boss said pick your career path because we basically don’t have it yet. So, I’m designing what I want my career path to look like and I’m creating my own titles, which is kind of cool. But of course, that will take seeking knowledge from different experts in the field. RAPS will be helpful with that—helping me know what’s available out there and these are the possible directions your career path can go.
How did you hear about RAPS?
My boss told me to sign up as soon as I was hired. I had no idea what it was. I didn’t know how resourceful it was until I decided to pursue my RAC (Regulatory Affairs Certification). When I started pursuing my RAC, that’s when I started signing up for everything that popped up. The first class I did was a fundamentals class on pharmaceuticals and there was so much information. It was a day-long class where they covered everything from CMC to safety and clinical and non-clinical. It was my first crash course. Even though my boss had me sign up for RAPS it became a huge resource for me. I’m really passionate about training. When I go to conferences or when I go to a virtual conference or a training, I get a lot of information that I can pass onto my team and other people in my company. So, it’s been a helpful resource.
What would you tell someone on the fence about joining RAPS?
The regulatory industry is so ambiguous and there are so many things out there that might not be the best resource. There is a lot of misinformation out there and to have a group of people who are dedicated to helping you out and giving you the best information is so beneficial. There are different things like a forum where you can go in and ask questions. A lot of times in our industry you might know the answer because you’re the first one to do it, or you’re the second one, but you can reach out to that network, and they’ll answer your question. It’s really helpful to have that at your fingertips.
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How has having your RAC helped your career?
Even though I had worked in the lab, and I had that quality experience, the acronyms were killing me. And there were a lot of things that even though I had heard it, I didn’t know the language of the industry. Going through the RAC certification process has helped me get to a point where I can speak that language with people. I might not know 100% of what they’re saying but it helps me to know where I should start in my research to get closer to finding out what they’re referring to.
Another cool thing about getting my RAC is I was able to see the process from the beginning to the end. From the point of developing the product and creating the prototypes to putting something on the market. My company doesn’t have an approved product on the market yet. So, we’re currently going through our BLA (Biologics License Application) process. A lot of our products that we do sell don’t require marketing approval, so I only have a snapshot of what that process looks like in the lifecycle of the product. To be able to know what happens from the beginning to the end, and to know what to do post-market was very helpful to me. It puts me in a position where I’m able to help my company look into the future and say, “Hey, I know it’s going to be another two years before we apply for the BLA. But when the time comes, you’re going to need to do this, you’re going to need do that.” It’s really helping with the planning side of things and it’s helping me realize why we’re doing certain things, so I would definitely recommend it.