Holly Groelle, PhD, Rac
About Holly Groelle, PhD, Rac
Holly Groelle, PhD, RAC, is the Sr. Manager of Regulatory Affairs at BeiGene in the San Francisco Bay Area, with extensive experience in regulatory affairs and a strong background in various scientific disciplines.
Title
Holly Groelle holds the position of Sr. Manager, Regulatory Affairs at BeiGene, located in the San Francisco Bay Area.
Current Role at BeiGene
Holly Groelle is currently working at BeiGene as the Sr. Manager of Regulatory Affairs. In this role, she has developed and implemented regulatory strategies for hematology oncology monotherapy and combination therapy global regulatory IND and NDA filings. She brings expertise in managing risk and providing guidance to achieve efficient regulatory approval for molecularly targeted investigational products.
Previous Experience at Principia Biopharma
From 2019 to 2020, Holly Groelle served as the Manager of Regulatory Affairs at Principia Biopharma in the San Francisco Bay Area. During her tenure, she managed regulatory affairs, contributing to the company's strategic initiatives in regulatory filings and compliance.
Roles at PPD
Holly Groelle worked at PPD in various capacities starting as Sr. Specialist, Global Regulatory Affairs from 2012 to 2013 in Raleigh-Durham, North Carolina Area, and then as Principal Specialist, Global Regulatory Affairs from 2013 to 2019 in RTP, North Carolina. During her six years as Principal Specialist, she played a crucial role in managing global regulatory affairs, ensuring the effective regulatory approval of biomedical products.
Market Research Experience at OTR Global
Before switching to regulatory affairs, Holly Groelle worked at OTR Global as a Market Research Consultant from 2008 to 2012. During her four-year tenure, she specialized in market research, acquiring valuable insights into the healthcare market landscape.
Educational Background
Holly Groelle's academic journey is extensive. She earned a Ph.D. in Biochemistry from Boston University School of Medicine and completed postdoctoral fellowships in Neuroendocrinology at Marine Biological Laboratory Woods Hole, MA, and in Infectious Disease at Dana-Farber Cancer Institute under the Harvard Postdoctoral Fellow program. She also holds a Bachelor's degree in Microbiology from the University of Maryland and a Regulatory Affairs Certification (RAC) with a GPA of 4.0 from Northeastern University.
Specialization and Expertise
Holly Groelle has a strong background in multiple disciplines including immunology, oncology, neuroscience, infectious disease, cardiovascular, and metabolic disease. She specializes in small molecules, biologics - cell and gene therapies, and combination products. Her interdisciplinary expertise significantly aids in the regulatory approval processes.