Leaving FDA for pharma and 30 years of RAPS membership with Andy Papas

Andy Papas is the vice president of regulatory affairs at NSF International. He joined us at RAPS Convergence 2022 in Phoenix for a chat about his career path, his experience as a longtime RAPS member, and more. This conversation has been lightly edited for clarity. 

How did you get into regulatory affairs? 

I started my career 40 years ago working for FDA as a chemist. Once I left FDA, there was a world of opportunity to work for a pharma company to leverage what I had learned at FDA as a scientist. But what I really like about the regulatory affairs profession is you're at the intersection of a level, several different disciplines. You're there to influence, but you have no authority to influence and you have a whole wealth of experts in various fields of drug development, clinical development, manufacturing, etc. So it's just that broad-based information and assimilation that needs to be done. 

What is your current role and what does it entail? 

I head up a regulatory affairs practice for pharma, biotech, and so we have clients outside of the US, we have clients inside the US, and my day-to-day role varies quite a bit simply because the nature of the projects that I have. It's very different than sitting in a single company. And, and so it could be it could be labeling, it could be OTC drugs, it could be clinical development, it could be post-approval submissions, it could be FDA meetings. It's just the whole spectrum.  

What do you get out of RAPS membership?

I found out when I started professional and traditional regulatory affairs role in a company, it was clear that this was a professional organization that was going to help me learn and so I joined very early in my career and have stayed with it. It's been very helpful. Like I said, my role keeps expanding and this is a great environment for learning from others. I came in with a knowledge of small molecules and over the years I've expanded to biologics and now I've expanded into devices, combination products. 

What has your experience been like as an attendee and speaker at RAPS Convergence 2022?

One of the reasons why I'm here at RAPS Convergence is cell and gene therapy, to learn more about that. We have some clients, but it's a growing field and I wanted to hear from the experts. The talks have been very high quality and I've learned some of them as opposed to a very fundamental, simpler level. So there's been a learning in all of the sessions. I think it's more of extrapolation from where I was. 

I was just at a session on international approvals and how quickly they've been able to do it. I was involved with that 20 years ago and it would take us two years to get to that point where they they've achieved it in six months. I've learned that not everybody has the knowledge and experience—and being a consultant, you get exposed to a lot more—so I have this particular vision on combination products that I want to talk about because it only represents maybe 5 percent of combination products. So there's a learning that I wanted to share with others.