What’s more important than knowing the regulations? Getting to “deliver high-quality products.”
Working in regulatory affairs means becoming intimately familiar with a long list of regulations, laws, guidances, and acronyms. But that should not prevent you from focusing on the ultimate goal.
"To make sure the medication patients are currently getting, or will get in the future, is of the highest quality”,” says Jonathan Amaya-Hodges. “That’s still the bottom-line motivating factor for me.”
In an interview with RAPS, Jonathan walked through his career path from engineering to quality to regulatory affairs, and from a large corporation to his current role as consulting director at Suttons Creek. This interview has been lightly edited for clarity.
How did you find your way into a career in regulatory affairs?
It was not intentional by any means. I started as an engineer in product development at Baxter. I thought the industry was compelling. Supporting products that have an impact on patients’ lives is important, and that's always been a motivator for me.
I made the move into quality and did that for a number of years. One day, I was on a cross-functional interview panel where we were hiring for a regulatory role within the device group at a pharma company. We interviewed some candidates, offered some people, but things didn't work out. Then the hiring manager turned around to me and said, “Do you want to do this?” And I said, “Okay, I was never really thinking about that but now I will.”
At that point, I knew the regulations well. I had followed the regulatory news and whatnot. I think our company was a RAPS Enterprise Member around that time. I had mostly thought about regulations in the context of my role in quality. To establish and follow processes, you need to know the regulations. I already understood the role of regulatory, having worked with them for my entire career. I like the more strategic elements working in regulatory affairs. The high-level planning appealed to me; that, and the fact that I could still work with the types of products, the people, and the groups that I knew, and apply things differently. I then jumped into that and did that for five years. I enjoyed that I got to work my way up and found that really valuable from a development perspective.
What do you do now in your role as consulting director at Suttons Creek?
I'm director-level management at a consulting firm where we do regulatory consulting. We do quality and development engineering consulting specific to combination products. What we specialize in is also what I've done through most of my career. Now I get to apply my total career experience — including regulatory, which obviously bleeds through everything — to all of our projects, because we consult on regulated products where the regulatory pathway, the regulatory submissions, clinical, commercial, all geographies, etc., are front and center. But I also get to apply my knowledge in other areas, the quality, the development side, the technical side. I get to integrate it with everything, which is pretty great.
You hinted at this above: what do you find appealing about regulatory affairs, just at a basic level?
I guess I'm getting old enough now that I've been a part of a number of projects. I've supported products on the market at multiple companies that have an ongoing impact on people’s lives. Being part of the regulatory process allows me to make sure the medication patients are currently getting, or will get in the future, is of the highest quality. That’s still the bottom-line motivating factor for me. Yes, it is obviously important that it meets regulatory standards and all that, but ultimately the point is that we can deliver the best quality product.
What is the most exciting or challenging part of your job right now?
There's exciting stuff all the time. What’s challenging? It's probably just the volume of work. It doesn't stress me out as much anymore, because we are continuing to expand our team. As a consultancy, it's a good problem to have, and it's also exciting. I'm an engineer by degree, so I like to problem-solve technical issues, or business challenges, or regulatory challenges. When I'm on calls with clients and a question or uncertainty comes up, I'm excited to try to help solve their problems.
An exciting part about being a consultant is also just the wide variety of projects, product types, and clients you work with. It's kind of refreshing. There are pros and cons to anything. Being a part of an organization and a team and knowing the product inside and out definitely has its advantages. On the other hand, it can get stale for some people, and it's exciting, having new things to work on all the time, and to be able to help people out. I'm fortunate to know a lot of people in the industry, and sometimes to be able to work with them professionally, no matter what company they're in and help them resolve some things, is fulfilling.
You have been pretty active in our RAPS Combination Products Collaborative Community. What motivated you to get involved with that, and why should other people consider joining?
I think being involved in industry or professional organizations is important for a number of reasons. Obviously personal development and knowledge and career growth, networking, everything that goes along with that, is very important. But to some degree, I am hopefully giving back a little bit to the regulatory field and helping others develop their knowledge in the industry. I've tried to do this throughout my career. Whatever the forum, always be open to discussion and participation, because you never know what could happen. Down the road, someone could connect you with a job, connect you with somebody that you can hire in the future, someone you could collaborate with on a project, or someone who could help you do research or expand your knowledge.
And again, especially if you like doing this, and I certainly do, then it's a way to do it more. It's just enjoyable, connecting online and then going to conferences and events. It helps you expand your knowledge. It gives you the chance to share your knowledge with others. It lets you spend time with people who hopefully enjoy doing the same thing that you do, even if that's in-the-weeds regulatory stuff.