Lynne Georgopoulos
VP Regulatory Affairs and Quality Assurance
Ms. Georgopoulos is a registered nurse with over twenty years experience in healthcare and pharmaceutical drug development. Recently, she was the Vice President of Clinical, Regulatory, and Quality Assurance at BioRexis Pharmaceutical Corporation, where she managed the development and implementation of clinical and regulatory strategies for the company’s biopharmaceutical drug product candidates. She directed the continuing review of corporate compliance to affect improvements, reduce cost, enhance efficiency and improve quality and compliance with GCPs, GLPs, and cGMPs for the company’s Phase 1 manufacturing facility, and played a key role in facilitating the merger and acquisition of BioRexis by Pfizer in 2007.
Previous to that, she was Vice President of Clinical and Regulatory Operations at Summit Drug Development Services, LLC, a small CRO providing product development services to the pharmaceutical and biotechnology industry. Before that, Ms. Georgopoulos was at ViroPharma Incorporated where over an approximate 7 year period built a focused yet flexible clinical development organization covering Clinical Operations, Clinical Drug Packaging, Regulatory Operations and Archive, and Drug Safety that maintained a high level of compliance while meeting ViroPharma’s changing corporate objectives. This resulted in her appointment as Director of Clinical and Regulatory Operations and ultimately led to a position as Director of Regulatory Affairs. Previously, she also held positions of increasing responsibility in clinical research for Sanofi Pharmaceuticals and Centocor. Earlier in her career, Lynne was a Study Coordinator at the Philadelphia Veterans Administration Medical Center and held positions as an ICU and staff nurse in the areas of cardiology, neurology and oncology. Lynne received her Bachelor of Science degree from Russell Sage College, New York and is Regulatory Affairs certified by the Regulatory Affairs Professionals Society.
