Susan Carter

Director, Regulatory Science

As a Director, Regulatory Science, Susan provides scientific and regulatory advice to clients for the development of small molecules and biologics particularly with regards to rare diseases. The projects she manages are in various stages of development, from nonclinical through to marketing application.

Susan comes to VCLS with over 15 years of experience in the biopharmaceutical industry. Her experience includes positions with large, global companies (Pfizer, Abbott), a small start-up biotechnology company (Valentis), and consulting firms (Cotè Orphan, PPD). Her regulatory experience includes developing regulatory strategies and feasibility assessments; in-depth interactions with the US FDA from preparing Type A/B/C meeting requests/ briefing packets to leading/managing regulatory interactions; IND/NDA/BLA preparation and maintainence (eCTD); and preparing FDA applications for orphan drug designation, breakthrough therapy designation, fast track designation, target product profile, rare pediatric disease priority review voucher, and request for designation. Susan has worked with a variety of Offices and Divisions within the US FDA. She has extensive experience in orphan drug development in a variety of indications and works closely with the Office of Orphan Products Development. Susan’s other recent Agency interactions have been with the Office of Hematology and Oncology Drug Products; Division of Cardiovascular and Renal Products; Division Neurology Products, Division of Metabolism and Endocrinology Products; Division of Gastroenterology and Inborn Errors products; Office of Combination Products; and Labeling Team Development.

Additionally, Susan has extensive clinical operations experience that includes developing clinical protocols (clinical endpoints, inclusion/exclusion criteria) and informed consent documents; interacting with key opinion leaders,data safety monitoring committees, and ethics committees; and clinical development plans. She has managed global Phase 3 oncology and anti-infective trials and was a clinical lead on the subsequent marketing application approvals. 

Susan earned her Masters in Regulatory Science at the University of Maryland School of Pharmacy. The curriculum included pharmacokinetics/pharmacodynamics and CMC.

Susan is based in the Washington DC area, close to the US FDA.

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