Renea Faulknor, PhD
About Renea Faulknor, PhD
Renea Faulknor, PhD, is the Senior Manager of Global Regulatory CMC Biologics & Cell Therapy at Bristol Myers Squibb, with extensive experience in regulatory affairs and biomedical engineering.
Company
Renea Faulknor currently works at Bristol Myers Squibb as a Senior Manager in the Global Regulatory CMC Biologics & Cell Therapy division. Bristol Myers Squibb is known for its focus on innovative medicines for serious diseases and has a significant footprint in the biologics and cell therapy sectors.
Title
Renea Faulknor holds the position of Senior Manager, Global Regulatory CMC Biologics & Cell Therapy at Bristol Myers Squibb. In this role, she is responsible for providing regulatory CMC strategies for both clinical and commercial submissions.
Education and Expertise
Renea Faulknor earned her Ph.D. in Biomedical Engineering from Rutgers University, where she studied from 2010 to 2015. She also holds a B.S. in Biomedical Engineering from the University of Rochester, completed in 2010. Faulknor has extensive expertise in authoring and reviewing CMC-related sections for regulatory submissions pertinent to biologics and cell therapy products.
Background
Before her current role at Bristol Myers Squibb, Renea Faulknor worked at Celgene, initially as a Consultant and then as Manager of Global Regulatory CMC Biologics in Summit, NJ. She has also served as a Harvard Post-Doctoral Research Fellow at Massachusetts General Hospital and interned at Merck Group. Additionally, she has spent time as a Research Assistant at the University of Rochester School of Medicine and Dentistry.
Achievements
Renea Faulknor has been instrumental in authoring and reviewing CMC-related sections for various regulatory submissions, including CTAs, INDs, BLAs, MAAs, J-NDAs, and NDS. Her work ensures that biologics and cell therapy products meet stringent regulatory requirements, enabling them to move efficiently through clinical and commercial phases.