Taylor Burtis, Senior Consultant of BPTC’s advanceONE™ Division, has over 30 years of regulatory and senior management experience. She has developed and implemented regulatory, GxP compliance, and inspection readiness strategies at multiple life science companies of biosimilars, vaccines, cell therapy, fusion proteins, antibodies, and other recombinant protein drug products. Before joining BPTC as an independent Senior Consultant she worked with virtual and large Pharma companies managing IND/CTA, BLA/NDA/ MAA filings and FDA Type A,B, C and EU Scientific Advice meetings. Prior to her consulting role, Ms. Burtis has held senior-level regulatory positions in the biopharmaceutical industry as: Vice President of Regulatory and Quality Affairs and Compliance at both Tokai Pharmaceuticals, Inc. and Novelos Therapeutics; Associate Director for World Wide Regulatory Affairs at, Wyeth BioPharma (now Pfizer); and Senior Manager of Regulatory Affairs at, Genentech. In addition, Ms. Burtis was an FDA Consumer Safety Officer in the Office of Compliance at the Center for Biologics Evaluation and Research (CBER). Before entering the life science industry, she spent 18 years as a laboratory manager and research technologist at Duke Medical Center, North Carolina Medical Center, Yale-New Haven Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, New England Medical Center, and the National American Red Cross. Ms. Burtis has a BS in Biology and Secondary Education from Framingham State College and a MBA from Simmons College. She has also held certifications from the American Society of Clinical Pathology as a Medical Technologist, Specialist in Hematology, and Specialist in Immunohematology.
