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My extensive international experience in regulatory affairs and quality assurance management, working under multiple regulatory systems such as the FDA and European Medicines Agency, informs my work and my teaching, allowing me to bring a highly informed and complete perspective to my students.

Seppe de Gelas

Academic Professional

I am located near Brussels in Belgium and hold a degree in peptide chemistry from the Free University of Brussels. My career began over 25 years ago in clinical research at Bristol-Myers Squibb, and over the years, I have evolved into roles in Quality Assurance and Regulatory Affairs at several pharmaceutical production units, including Baxter International, the Belgian-based headquarters of UCB, and Lonza.

Between 2010 and 2015, I owned my own laboratory where I conducted QC testing and batch release for the European market. More recently, my responsibilities have included auditing a myriad of pharmaceutical and medical device suppliers and subcontractors, and serving as a QA & RA director at a medical device startup company, which is ISO13485 certified and focuses on developing a subcutaneous continuous glucose sensor. Currently, I hold a position as director of QA & Regulatory Affairs at Hyloris Pharmaceuticals, a virtual pharmaceutical company that specializes in products using the FDA’s 505b2 regulatory approval pathway.

Since 2017, I have also been a faculty member at the UGA, teaching various classes including European regulatory affairs and Process Control & Process Validation.

Specialties: quality assurance, contact with health authorities, FDA inspections, quality systems, regulatory affairs.