In this article we shine the spotlight on Daniela Gerl. Daniela has been with NDA since 2011 and excels in supporting our clients during the development of their medicinal products with strategic and operational advice for small and large molecules, throughout all stages of development.

When everything comes together

Working as a principal consultant and leading complex drug development submission projects, not only requires someone with experience, regulatory understanding, and a problem-solving mindset, but also diplomacy, composure, and the confidence gained from having a great team around you. Daniela Gerl, principal consultant at NDA, embodies all these qualities so when the unexpected happens, which it often does, you can rely on Daniela to be calm and already planning for what should happen next.

After graduating as a pharmacist, Daniela joined a small generics company, this role introduced her to the world of regulatory affairs and was an excellent environment to learn and grow. “Back then”, Daniela explains, “my team acted as the medical affairs department, the regulatory affairs department, the pharmacovigilance department, and sometimes we even supported our colleagues in sales and marketing. It was a steep learning curve for me”.

After five years, the company was bought by a large pharmaceutical company and Daniela faced a new challenge, managing the complete restructure of the regulatory affairs department at a different site. Daniela needed to juggle building the new department, hiring, and training new people whilst maintaining project related work, and making sure deadlines were met. Being the level-headed person she is, Daniela was not overwhelmed by the situation, but rather thrived on the challenge.

Daniela has a very healthy work-life balance which has always served her well, and even more so today, as like many of us, she has been working from her kitchen table for over a year due to the pandemic.

“I cope well with stressful situations”, she says, “and when I’m off work, I can shut it off completely”.

Daniela had not considered working as a consultant and it was actually her previous manager at the generics company that introduced her to NDA, ten years ago.

“I was pragmatic about the idea and started working as a freelancer”, she remembers. “I saw it as a transition and thought that I would most likely move on, but as it turned out, being a consultant was a perfect fit for me. Here, at NDA, I always have a wide range of projects on my desk, it’s like a promised land for someone like me who thrives on learning new things”.

“For me, the only downside of being a consultant is when the project is over. I often have to move on to the next project while the client’s success journey continues on without me. But that’s also what provides me with the variety that keeps me on my toes”.

Daniela enjoys interacting with people, the highly creative innovators on one hand, and the meticulous agency representatives on the other, creating understanding for the common goal, i.e., an approval of a Market Authorisation Application. The crux of the submission is that it requires a number of complex workstreams to all come together and here Daniela plays a crucial role.

Seeing the big picture and making all the pieces come together is what she loves the most. Relying on the team and all the subject matter experts to deliver on time is a stressful role but Daniela has her own way of dealing with the tension that might occur when things need to be reshuffled and plans are changed in the final hour.

“I focus on the big picture, the must-haves and what is absolutely necessary to move the project forward and deliver accurate information”, she explains. “Trust lies at the heart of every strong relationship, and I completely trust my team to handle the details. We have each other’s backs and that’s what allows me to sleep at night, no matter what challenge I encounter”.



Daniela Gerl

Principal Consultant

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