Holly McCaleb

Holly McCaleb has extensive experience in regulatory affairs and biochemistry, currently serving as a Director at Pfizer since December 2006, where responsibilities include overseeing CMC regulatory filings for clinical trials in multiple regions and facilitating interactions with health authorities. Prior to this role, Holly held various positions at Pfizer, including Senior Regulatory Manager and Senior Scientist, focusing on global regulatory strategies for biologics and scientific research in biotherapeutics. Holly's early career includes a contractor position at Pfizer and a Graduate Research Assistant role at Texas A&M Health Science Center, where research centered on protein import into mitochondria. Educational qualifications include a Master's degree in Bioscience Regulatory Affairs from The Johns Hopkins University, an MS in Biochemistry from Texas A&M University, and a BS in Biochemistry from the University of Nebraska-Lincoln.