In regulatory affairs, “mentorship is about hope"

While a regulatory affairs career can take many paths, almost everyone who works in the field will tell you they had someone help them out early in their career. For Angelina Lisandrelli, it was a failed mentorship that ignited her passion for helping others in the regulatory field.

“The lessons I learned with this person changed me and made me a better mentor now,” she says. 
Angelina is the director of regulatory and quality at RespirTech. She is a member of the RAPS Membership Committee and serves as the vice chair, membership, of the RAPS Twin Cities Chapter.

She spoke with RAPS about her path from chemistry to regulatory and quality, how she became a fierce advocate for the RAPS Mentoring Program, and more. Our conversation has been lightly edited for clarity.

How did you find your way into the regulatory profession?

I started in a contract lab as an R&D chemist and then moved into GMP chemistry, which is where I got my first exposure to regulations and standards. After that career, I moved over to Medtronic and worked on a combination device. That is really where everything started to accelerate for me. I was developing and validating methods. You're getting exposure to the regulations and standards, and fundamentally many regulatory folks contacted me to review sections of their submissions or aid in deficiency responses. Eventually, I stepped out of the lab and went into regulatory, and I have loved it ever since as it's complex, it requires strategy. It requires critical thinking. It requires an ability to navigate and be dynamic. I'm a person who loves puzzles and mysteries, so I really enjoy it. Regulatory fits that part of my mindset.

No two days are ever the same. It's not just "US regulations versus EU regulations." Each challenge brings a unique set of variables. That constant variation keeps me engaged, fuels my curiousity, and pushes me to keep learning.

What was the first role that you took in regulatory? And what was that transition like?

I had recently just become a senior chemist in the lab, and, as I mentioned, regulatory professionals usually reach out to their subject matter experts to answer deficiencies. One of these people ended up being my first real mentor, and he was in the regulatory group that was associated with the submission. That sparked my interest — where are my responses going? They explained, "well, this eventually will go to the FDA to answer a question."

When a senior regulatory affairs positions opened up, I realized that many of the skills I had developed as a chemist — along with my quality experience in the lab, such as familiarity with standards and regulations — were highly transferable. That foundation helped me make a smooth transition into regulatory affairs.

What led you to your current role as director of regulatory and quality at RespirTech?

I've been in a management role before, and like many leadership journeys, it had both rewarding and difficult moments. There was one situation in particular that made me question whether I wanted to step into people management again. But with time and perspective, I realized those challenges were valuable growth opportunities — and they've helped shape the kind of leader I strive to be today.

"Do you believe you can do this? Will you believe that you'll put the energy into it? And if no one's going to help you, what are you going to do to make it happen?"

After that experience, I transitioned into more of an individual contributor role as the head of regulatory file reviews at Philips, where I worked with different business units to support and guide their regulatory teams. If there were certain documentation activities, it was almost like a consultant or mentor role. It sparked once again what I loved about being a people manager: the ability to develop people and see them succeed. I'm passionate about helping business achieve their goals — but above all, ensuring patient safety is non-negotiable. Both are equally important to me, and I believe they go hand-in-hand when done right.

If you could go back in time and give yourself one piece of advice when you were entering regulatory, what would that advice be?

There will be people in your career who will cast doubt all the time. Tune those people out. I'm not saying to mute them, but tune them out slightly. Do you believe you can do this? Will you believe that you'll put the energy into it? And if no one's going to help you, what are you going to do to make it happen? I'm a testament that you can make it happen when you believe in yourself. I say this to all my 23 mentees. I encourage them to find resilience, use grit, and persevere. Every wall that you hit, hit it again. Because every time you hit it, a brick crumbles and something loosens up. You learn something about yourself, and that perseverance is key to a successful career.  Not just in regulatory, but in anything you do.

What's one project that you look back on particularly fondly in your career, or that you're especially proud of?

I still think back to those early EU MDR days. There was no clear roadmap, just a shared determination across the industry to figure it out as we went. At Medtronic, we were all learning together, doing our best to meet the regulations’ demands for the very first time.

One of the most defining projects of my career emerged from that period. I spent nearly 30 to 40 hours a week on teams meetings, building out the technical documentation and medicinal dossier for a combination product. This submission was massive— over 15,000 pages by the end—and the pressure was intense. As it was one of the first EU MDR submissions, we received a flood of questions on the technical file, but only one on the medicinal section, which felt like a major win.

The process was grueling. It was the height of COVID in 2020, and at times, we looked like zombies from the long hours and sheer volume of work. And yet, the documentation we produced ended up setting a precedent—others began to use it as a model. I couldn’t have been prouder of what we accomplished. What made it even more meaningful was the personal connection. This submission involved a DCB balloon, and when I was eight years old, my grandmother passed away from complications related to a PTA balloon. Working on this felt like a full-circle moment. It wasn’t just regulatory work — it was deeply personal.

Looking back, that experience planted the seed for why I’m so passionate about mentoring and supporting others in regulatory affairs today. It showed me that submissions aren’t just documents; they reflect the people and purpose behind them. And that purpose — keeping patients safe — has never been more apparent to me than it was in that moment.

You have been a very public advocate for the RAPS Mentoring Program. Why?

When you come out of a master’s program and enter the industry, there often isn’t a clear bridge or guidance. New graduates — or those trying to move into regulatory — are left to figure things out the hard way. I was fortunate to be surrounded by a wonderful group of women mentors, but not everyone has that kind of support. I once had a mentor who, in many ways, felt more like a tormentor. Looking back, that experience taught me exactly what not to do as a mentor. It showed me how critical empathy, encouragement, and honest support are in helping someone grow—not just professionally, but personally too.

That experience is a big reason why I’m so passionate about mentoring today. I bring those lessons to every one of my 23 mentees. I want to be the kind of mentor I wish I had early in my career—someone who sees your potential, helps you navigate the tough moments, and reminds you that you belong in this field.

So when I found out that RAPS was developing this mentorship program, I had to get involved. I saw it as the bridge for regulatory professionals. RAPS is the only organization that has stepped up with a real solution, and I’m incredibly proud that this mentorship program exists. This program can be that bridge—from academia to industry, from quality to regulatory, or even from pharmacy tech to regulatory. It’s designed for anyone looking to grow. And honestly, if you’re not taking advantage of this opportunity, you may be holding yourself back from where your career could truly go.

I encourage everyone to check it out. Just try it. Even if you’re unsure about time—there’s flexibility. You can have a one-meeting relationship if that’s all you can commit to. When you’re early in your regulatory career, you need someone who’s already walked the path—someone who can offer you the light at the end of the tunnel. Mentorship is about hope. It’s not about holding hands; it’s about saying, “You’ve got what it takes. Let me help guide you there.”

Join the RAPS Mentoring Program and become a regulatory mentor or mentee today.