Why working in regulatory means seeing the big picture

Larry Liberti is the director of the DK Kim International Center For Regulatory Science and an associate professor in the department of regulatory and quality sciences at University of Southern Californiais who has been a RAPS member since 1996 and is a member of the RAPS Board of Directors. We sat down with Larry at RAPS Convergence 2022 to talk about career trajectories, regulatory knowledge bases, and why continually seeking mentors and guidance at all stages of your career is crucial to meaningful professional success. This conversation has been lightly edited for clarity. 

How did you get started in regulatory?

It was not a straight shot. It was one of those situations where when I first went to work at Wyeth Labs right out of grad school, I went to work in what was called product evaluation and stability. Well, there were a lot of interactions with the regulatory team then. From there, I moved into clinical writing and then into pharmacovigilance, and then within all these different sections I found I was interacting with the regulatory folks. What I enjoyed about regulatory, their approach, was that they saw the big picture. They were able to put together lots of bits and pieces of information into the kinds of responses they might have to give to regulatory agencies or putting together the filings and submissions. Eventually, I migrated to the regulatory arena, but it was because of my exposure to all these other activities that I did within the companies that gave me the ability to talk across all these different areas to the people in regulatory, and eventually with the regulators themselves. 

What do you like about working in regulatory?

One of the great things about regulatory is the distinction between breadth of knowledge and depth of knowledge. Especially in pharmaceutical companies, there are specialists, people who understand their particular area in great, great depth. What I found is that my colleagues in regulatory, like myself, ended up being a little more generalists. Our breadth of knowledge was very big, so we could talk to people in product development, in pilot plants, people in production, stability, throughout the full gamut, even post authorization. And there weren’t that many people within the organization that had that broad scope with the ability to speak and to think about the broader aspects of getting a product to market. 

Why is the regulatory profession so important?

I think the regulatory profession itself is really important because it sets the standards for the quality, for the kinds of people who get into the profession. So, having an organization like RAPS, providing professional support, providing a community for regulatory professionals is really important because the regulatory professional often becomes the glue within an organization. The smallest of organizations turn to their regulatory team for advice, for counsel, for ideas about the way forward even very early on in product development. So, having an organization like RAPS supporting the entire profession, I think it’s really critical to continue with the high-level professionalism of regulatory. 

How did you first learn about RAPS?

I was introduced through colleagues in the industry who had participated in RAPS activities, and when I first joined RAPS, I wasn’t quite sure how it would help me. But what I learned pretty quickly was that it was a community, and because it was a community, I was able to network and learn from others. And that’s when I found out about the RAC (Regulatory Affairs Certification). I was about 10 years into my career when I sat for the RAC. It was challenging. There’s no doubt about it. But, it was very, very rewarding to be able to pass the RAC examination and to use that as part of the background that I have and to explain to people that an RAC is actually a very good qualification that gives a particular standing to those who have gone through the process, to those who have shown that they have a particular knowledge base. 

What do you get out of RAPS membership?

There are a lot of organizations that a person can join nowadays, professional organizations of all sorts. But what I really like about RAPS is that it’s a tight-knit community. Often, we’ll meet and say, “what a small world that you are here or I’m at a particular event with you,” and that represents a way of us building on each other’s experiences and learning from each other. I would encourage people to continue to participate in RAPS and join if you’re not a member because it’s a great place to meet people and build real community. 

Learn more about the exclusive benefits of RAPS membership. 

What role has RAPS played in your career?

So, now I’m semi-retired and when I look back on how RAPS played a role in my career, it’s done two things. One is that it’s provided me with a community to interact with, which is so important. Because you’re always looking for a mentor. Even now I look for mentors to help me answer questions, give me guidance. And the other aspect was the education RAPS provides. I could always go to RAPS and take a course, to interact at the chapter level, go to a webinar, and new technologies have made it so much easier for me to access knowledge bases in RAPS. So, those things, community and training, and knowledge are at the core of what has kept me involved in RAPS.

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