How regulatory affairs connects science to patients

There’s no one correct path into regulatory affairs. 

If anything, one of the most common ways to get into regulatory affairs is “by accident.” That’s how Eleanor Panico, director of regulatory affairs at Eisai, describes the beginning of her regulatory affairs journey. 

Eleanor joined us at RAPS Convergence 2022 in Phoenix for a chat about the regulatory profession, her path into it and much more. This interview has been lightly edited for clarity. 

Why do you think regulatory affairs is important? 

I think that the regulatory profession is very important because it is essentially the conduit between the science that can be very complex, very advanced, very innovative and your job as a regulatory professional or regulatory scientist is to be able to communicate these concepts in a way that will translate to, "What does this do for the patient?"

How did you get into regulatory affairs? 

I got into regulatory affairs kind of by accident, I think probably similarly to many people. After graduate school I joined a consulting company that was quite small. It had two sides of the business. One was regulatory and scientific consulting and the other was defense for pharma, essentially counsel. I pretty much started working exclusively on the regulatory side and I found that it fit me quite nicely as a personality and also allowed me to leverage some of my strengths: having a scientific background while also having a pretty good knack for writing and communicating important messaging on, "what will this mean to people who have access to it, ultimately, in the market?" Sometimes that's not always easy. And "what do we have to do to get from point A to B to C, D to have to G, and ultimately to market?" It just seemed to be a good fit.

What is your current role and what does your day-to-day look like? 

So, my current role is I work as a US and global regulatory strategist for a Japanese company. I specialize in neurology and oncology products mostly. So, my day-to-day can vary depending on the products I'm working on. Right now we're in some early and mid-stage development, so a lot of what I do is liaise with my cross-functional teams in order to submit clinical trial applications, submit protocol amendments, basically submit questions to FDA in order to see what we need to do for the next stage of development and ultimately build regulatory strategies for any upcoming assets that we might have.

What’s one career achievement you’re proud of? 

A one specific achievement that I felt was pretty impactful in my career was I had previously worked for a big company. Pfizer. You’ve probably heard of it. At the time that I joined the company, we were at the tail end of a 10-year study, and it was one of the biggest trials for cardiovascular outcomes, safety trials that I think has ever been done. 

Ultimately, I essentially served as a US lead for the closure of this journey. That included having an advisory committee discussion with FDA and ultimately to include the results of the position study into the United States prescribing information. It felt like a really proud moment and a good achievement because ultimately we had this discussion and closed off this journey ultimately that spanned 10-plus years because it was triggered by a safety issue. 

It just felt like things came full circle. And sometimes that really doesn't always happen. You just move on to different things. Even though I wasn't there for the beginning of the study, it felt like I was able to contribute to closing the book on this one really challenging project. 

How did you find out about RAPS? 

I found out I found out about RAPS at my very first job. I had a couple colleagues who were studying for the RAC exams and I found that this was a nice community to be able to meet other regulatory professionals, learn more about strategies that are being used globally in order to help get patients medicines that we’re creating and share ideas and collaborate. So thought it would be great to be a RAPS member. And luckily some companies allow you to be RAPS member through their corporate memberships, and even if I didn't have that, I would still be a RAPS member because I think it gives you access to a lot of good resources and access to things like this, RAPS Convergence, for your face-to-face and learning a lot about what people are doing, learning what's new and learning what's on the cutting edge of regulatory science.

How does RAPS help you with your job? 

They’re always providing resources and things for me to learn about. If there's also a question that I have on something I'm working on, I bet I could probably look it up and there might be an article or something about it on the RAPS website.

I do feel like there's a lot of opportunities also to strive within the regulatory industry. A couple of things that I plan on probably following up include helping to write for RAPS, maybe eventually the RAC credential. I think RAPS has improved my knowledge of regulatory science and just given me opportunities to learn.

Learn more about RAPS membership today.

Regulatory affairs jobs can be difficult to explain to non-regulatory folks. How do you tell people what you do for a living? 

I think regulatory science and strategy is something that can be a little challenging to communicate in terms of what we do. For me, I think I've gotten it down to pretty good science, though. What I tell people is that my job is to work with health authorities in order to serve as that liaison between my company and the health authority to see how we can get a drug in development from point A to point B and then ultimately to market. 

And so essentially how we do this is we work with our cross-functional team. We define key messaging, define questions, define the pathway that we want to follow as a company and then work as best as we can to make sure that this is aligned with strategies aligned across health authorities.