Dr. Jérôme Mordel, Regulatory Affairs Manager

What sets BioSpring apart is its people. Each team member contributes unique perspectives, experiences, and expertise, creating the foundation for our innovation and success. Meet our colleagues and learn more about their role, journey, and life beyond the workplace. Today’s spotlight is on Regulatory Affairs Manager, Dr. Jérôme Mordel.

Jérôme studied Biology and Physiology in France before earning his PhD at the University of Strasbourg in cooperation with the Max Planck Institute in Frankfurt. After completing an advanced training seminar in life science management, he worked in the regulatory affairs department, covering both drug substance and drug product manufacturing. He joined BioSpring in January 2022 as a Regulatory Affairs Manager and now supports clients with phase-appropriate regulatory submissions including IND, IMPD, NDA, MAA, J-NDA, and BLA.

What do you like about your work?

The variety of tasks in my job requires interaction with many different departments at BioSpring. Since we are involved in change management across various projects, we stay well-informed about what is happening throughout the company. I find it rewarding to see the continuous improvements that different teams develop and implement which aid our clients in accelerating their therapies to market and beyond. I also appreciate our close communication with clients—understanding their perspective and contributing to their regulatory submissions is very fulfilling.

How have your studies prepared you for working at BioSpring?

Working on a PhD is a challenge—you need to stay organized and be able to precisely document your work based on existing data. That is similar to preparing regulatory documents for our customers. During my studies, I also had to respond to reviewers’ feedback, which is a comparable process. The main difference is the teamwork: here, colleagues contribute significantly and complete much of the preparatory work in advance.

What are your daily challenges as a Regulatory Affairs Manager?

No two days are the same in regulatory affairs. Besides juggling different projects and keeping our customers informed about relevant updates to their products, we also help prepare the quality-related parts of regulatory submissions. The key is to provide just the right amount of information, depending on the project's development stage. Sometimes, customers forward questions from authorities at very short notice—and responding in time can be challenging.

Can you share a memorable project or accomplishment during your time here?

One of our clients recently received marketing authorization for their product—a great achievement that reflects collaborative work across all departments at BioSpring. Even in the final steps of the process, BioSpring supported the customer by performing studies, providing critical data, informing them about changes, reviewing submission documents, and responding to regulatory questions. When a customer succeeds in bringing a treatment to patients, it is a success for BioSpring, too.

What makes your work unique?

The regulatory landscape governing the manufacture of oligonucleotide-based products supported by BioSpring is evolving rapidly, driven by the growing number of approved RNA-based therapies. BioSpring not only implements current regulations with great proficiency but also plays an active role in shaping the regulatory frameworks of the future. It is inspiring to be part of a company that is both attuned to today’s requirements and engaged in shaping the standards of tomorrow.

What do you like to do in your free time?

Since the birth of my son last year, I try to spend as much free time as possible with my family. That said, I still make room for some of my favorite hobbies—reading, cooking, and gardening—which I hope to share with my son as he grows up.