Becky Robinson-Zeigler
Vice President Regulatory Affairs @Ssi Strategy
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WORK HISTORY
Vice President Regulatory Affairs @Ssi Strategy
NJ, US
Provide strategic regulatory advice to small, mid, and large-size biopharmaceutical and medical device companies manufacturing small molecule, monoclonal antibody, therapeutic protein, gene therapy, and drug-device combination products.
EDUCATION
Yale University
Master of Philosophy (MPhil)
Yale University
Master of Science (MS)
Columbia Engineering
Bachelor of Science (BS)
The Lovett School
HS Diploma
Yale University
Doctor of Philosophy (PhD)
ABOUT BECKY ROBINSON-ZEIGLER
Former Branch Chief at the US Food and Drug Administration (FDA) responsible for supervising pharmacology/toxicology review of advanced therapy medical products and combination products in the Center for Biologics Evaluation and Research (CBER). Former senior scientific reviewer of medical devices and combination products in the Obstetrics and Gynecology Devices Branch at the Center for Devices and Radiological Health (CDRH). Highly motivated and high-performing Biomedical Engineer and Regulatory Affairs Professional with diverse regulatory and scientific expertise. Accomplished leader adept at managing complex and diverse teams, and reconciling competing interests.Core competencies include: Cell Therapy Products • Obstetric Devices • Gene Therapy Products • Gynecologic and Urogynecologic Devices • Tissue-Engineered Medical Products (TEMPs) • Device Regulatory Strategy • Biologic-Device Combination Products • Biologics Regulatory Strategy • Drug-Device and Device-Drug Combination Products • FDA Product Jurisdiction • Hemophilia Products • Development of Consensus Standards • Reproductive Health Devices • Leadership • Team Building • Facilitation • Mentoring
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