Careers in Regulatory Affairs for STEM PhDs
Monday, August 11th, 5:30 – 6:30 PM CST
(Virtual)
Are you a STEM PhD interested in guiding scientific innovations through the complex landscape of regulations and approvals?
Join myCHOICE for a panel discussion with professionals working in regulatory affairs across biotech, pharma, and medical device industries. Panelists will share how they support product development by ensuring compliance with regulatory standards, preparing submissions for agencies like the FDA, and working cross-functionally with scientists, clinicians, and legal teams. Learn about career paths in regulatory affairs, key skills for success, and how to transition from academia into this critical and fast-growing field.
Roger Quan, PhD
Regulatory Affairs and Strategic Initiatives Advisor, Bright Path Laboratories
Dr. Roger Quan is currently a regulatory affairs consultant and adjunct professor. He left Abbott/AbbVie after a 20 year career that included stints in the R&D process chemistry, manufacturing and regulatory affairs organizations. While he was in the RA group for 14 years, Roger supported many developmental and marketed products including AbbVie’s first oncology product. In the last 7 years, he managed a group of regulatory professionals that supported small molecule, biologic and device programs. Prior to Abbott, Roger received a B.S. in Chemistry from the University of Michigan and a Ph.D. in Chemistry from California Institute of Technology. After spending two years as a post-doctoral scholar at Harvard, Roger was employed at Amoco Chemical Company for three years developing polymerization catalysts.
Sydney M. Gibson, PhD
Associate Principal, Real-World Regulatory Science & Strategy, IQVIA
Dr. Sydney M. Gibson is an Associate Principal at IQVIA, where she advises life science companies on using real-world data (RWD) and real-world evidence (RWE) to support FDA and global regulatory submissions. Her work includes drugs, medical devices, combination products, and AI-enabled technologies. Before IQVIA, Sydney was a Lead Reviewer at the FDA, where she evaluated regulatory submissions (510(k), IDE, PMA) for orthopedic devices and led cross-functional review teams. She also served as a biocompatibility expert across the device review office.
Dr. Gibson earned her PhD in Bioengineering from Rice University, studying the tumor microenvironment in lung cancer, and her BS in Bioengineering from the University of Pittsburgh. Her experience spans research, startups, government agencies, and regulatory consulting.
Terry Solomon, PhD
Principal Regulatory Affairs Specialist, Pulmonx Corporation
Dr. Terry Solomon is a Principal Regulatory Affairs Specialist at Pulmonx Corporation. She leads regulatory submissions for medical devices, including implantable products, capital equipment, and software-based tools. She has written successful FDA 510(k) submissions, supported global approvals in countries like Japan, Brazil, and Australia, and helped transition products to meet European regulations (MDR). Dr. Solomon earned her PhD in Biomedical Sciences from UC San Diego, where she studied the genetics of blood clotting. During her PhD, she completed a certificate in Regulatory Affairs to explore careers outside of academic research. After graduating, she worked at Natera, a genetic testing company, where she focused on regulatory compliance and preparing for new diagnostic regulations. Her work combines strong scientific training with knowledge of regulatory systems. She collaborates with engineers, quality teams, and international partners to bring new medical products to market. Her path shows how PhDs can use their research and analytical skills to build a career in regulatory affairs.
Gayatri Kaskhedikar, PhD
Senior Regulatory Affairs Specialist, Abbott
Dr. Gayatri Kaskhedikar is a Senior Regulatory Affairs Specialist at Abbott, where she supports global regulatory compliance and regulatory strategy for medical devices. She applies her expertise in regulatory compliance for On-market products to ensure devices meet both U.S. and international requirements.
Before joining Abbott, Gayatri worked at Regulatory Technology Services under the FDA’s third-party review program, reviewing Class II medical devices for compliance with regulatory and safety standards. She also has research experience as a Senior Research Associate at Illinois Institute of Technology and as a Research Technologist at Massachusetts General Hospital.
Gayatri earned her PhD in Biomedical Engineering from Illinois Institute of Technology and her Master’s in Biomedical Engineering from Louisiana Tech University. Her career path shows how advanced engineering training can lead to impactful roles in regulatory affairs, helping bring safe and effective medical technologies to patients worldwide.
