Daniel Vasilchuk on getting into regulatory from academia, working in cross-functional teams and why he wants to get his RAC

Daniel Vasilchuk is a CMC regulatory affairs manager at Regeneron Pharmaceuticals. He joined us for a chat about his career path, his current role and more at RAPS Convergence 2022 in Phoenix. This conversation has been lightly edited for clarity. 

How did you get into regulatory affairs? 

I actually was in academia for a while. I was postdoc for about six months at Rutgers University in New Jersey, and I was working one day and my wife sent me an interesting posting for a regulatory fellow at Regeneron. I thought it seemed interesting they were asking for somebody who wanted to learn more about regulatory, but who didn't necessarily have any regulatory experience, but had some of that technical expertise in stability testing, analytical characterization, things like that. 

So I applied and the rest is kind of history. I sort of fell I fell into it a little bit. I did not expect to be in regulatory affairs, by any means. I thought I was going to be working as a postdoc and then maybe go become an assistant professor, tenure track, things like that. But definitely glad that it panned out the way it did. 

What is your current role? 

My current role at Regeneron is manager, CMC regulatory affairs. What that involves is maybe 60 percent of that in program support leading CMC regulatory strategy and making sure that the industrial operations and product supply side of the business is able to proceed in compliance with FDA guidances and that we meet our goals in terms of getting drugs to market and then to patients. 

And then the other part of my role is really trying to see where we can improve our processes. So I'm heavily involved in continuous improvement. I am the representative for continuous improvement within our group. A lot of that looks at processes that we have right now that may need to be made more efficient. We're standardizing other processes that may not have a standard operating procedure that may need to be formalized and put down on paper so that somebody is able to do that consistently every single time. 

What do you like most about this job?

Definitely working in a cross-functional environment and meeting a certain goal, maybe something that has never been done before. So trailblazing, working with different departments, working with the FDA, working with our industry partners and our CMOs to reach that final goal that we want.  

How did you find out about RAPS?

I initially got introduced to RAPS with my interest in earning my Regulatory Affairs Certification. I've been part of RAPS because Regeneron is an enterprise member. I read the articles, I take in the content and everything. It's definitely exciting to be part of such a big organization where so many other people are very passionate about regulatory affairs. You might not meet that kind of a person out on the street, but here at RAPS Convergence for example, you have people that are really passionate about the field.  

You mention your goal of earning an RAC got you more involved with RAPS. Why are you interested in getting your RAC?

I have my bachelor's, I have a PhD and all of that is good for the technical expertise and knowledge that I do have. And it helps contribute to my current role as a manager in CMC regulatory affairs. But I'd love to know a lot more about the regional requirements, like in Health Canada, EU and globally, and make sure I fully understand the history from the very beginning when all the laws were really set into place. I think some people may take that for granted and they don't realize how much had to happen and how much has had to be put into law to get to where we are right now. So that's what I that's what really kind of drove me to get to pursue my RAC.  

What’s one thing you’ve learned here at RAPS Convergence that you plan to take back to your job?

(Chuckles) One of the, I guess, funniest things I've learned is at one of the Rimsys presentations. What we're going to take back to our department is that we shouldn't use color-coded spreadsheets anymore. We should try to have a system where it feels like a source of truth. We can back up what we say with a direct, formal record that lives in a quality system. 

It's been amazing here. Meeting all these new people and running into some old people that I met at previous conferences. So I've definitely enjoyed my time.