In this article, we shine the spotlight on Elizabeth Fenna, Principal Consultant at NDA, and learn how a fortunate stroke of serendipity pushed her into regulatory affairs.


A fortunate stroke of serendipity

Serendipity is an unplanned fortunate discovery; the moment when something you are not looking for finds you and changes your life forever. For Elizabeth (fondly called Liz) Fenna, Principal Consultant at NDA, that fortunate stroke of serendipity was falling into regulatory affairs.

Liz was born and raised in New York, but currently resides in the MetroWest area of Massachusetts with her pet rats, Ginger and Maryanne. She started her career as a chemist, working in the lab, then after a few years, moved to a plant where she worked in quality control and quality assurance. While at the plant, part of her role involved supporting the regulatory affairs team with documents such as batch records. Eventually, the company offered her a position in regulatory affairs.

“I was very lucky to fall into regulatory affairs in the late 1980s. When I started, we just had the regulations and that was it. In the United States, we had the CFR and maybe one or two guidance, so it was easier to be a generalist. I started working in generic drugs, which is basically CMC—Chemistry Manufacturing Control—so my chemistry background segued into regulatory affairs quite well.”

With this new opportunity dropped in her lap, Liz wanted to discover more about regulatory affairs. Her greatest desire was to work in a big pharma company, but none of them were willing to hire her without IND or NDA experience. So, she started working at a small hybrid company to get the experience.

In 1991, Liz joined Astra, which eventually became AstraZeneca and gained more experience in regulatory affairs. “We had a good mix of development projects though we were such a small team. At the time, we were only three people in regulatory affairs, and we were all assigned projects to handle. It didn't matter if the project was CMC, clinical, nonclinical-related, we handled everything in the project, and I really enjoyed it,” she says.

Preparation meets opportunity

Over time, Liz became more independent. She started working for numerous corporations, including large Pharma, multiple start-ups, and other consultant groups. She also contributed to multiple regulatory approvals in the US, establishing a new route of drug administration. However, she did not want to get bored and pigeonholed so she started looking out for companies engaging in more challenging and diverse projects.

In April 2022, Liz joined NDA Group as a Principal Consultant. She enjoys taking on multiple complex projects, working together with other experts and consultants, and contributing to the safe development of medicines.

“I chose NDA because it suited what I was looking for, being that they work on a lot of diverse complex projects. I love drug development because I feel that I am contributing to a better world. I mean it. Maybe it's a very small portion, but I know that for those clients, and the patients, it means a lot. Also, I enjoy my work and love my colleagues because, every day, I learn something new. I tell all my friends that my job is like going to school. It's like being in college and that is what I look forward to every day.”

Fortune favours the bold

With over 30 years of experience, Liz has worked as a regulatory generalist with expertise in all phases of drug development and multiple regulatory subspecialties with multiple products. She considers it a plus working as a generalist in a field that is now highly subspecialized. In her words: “It is not difficult fitting in because, as a generalist, you enjoy the best of both worlds. We usually say that we are conductors. Regulatory affairs is like an orchestra where everybody plays their instrument, but as a regulatory generalist, we make sure that everybody is coming in at the right time—that we're all at the same pace and everything is in sync.”

Liz exudes a love of life and has a diverse set of interests outside of work including animals, art, and nature.  She also enjoys festivals, fairs, and gardening. Her most important words of wisdom for success are to be your authentic self.

“Be yourself and be authentic. It could be one of the hardest things to do because you have to expose your vulnerabilities. However, I believe it really is the key to success and non-success because sometimes things don't go the way you want them to. It is great to listen to other people’s opinions but understand that you can't please everybody. That is why you need to be authentic!”

 

About

Elizabeth Fenna

Principal Consultant

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