Jeannie Skinner

Jeannie Skinner has over 30 years of experience in Regulatory Affairs. Jeannie began their career in 1987 as a Senior Manager of Regulatory Affairs at Hoffmann LaRoche, where they were responsible for preparing IND, NDA and BLA submissions for anti-infective, anti-malarial, oncology and antiviral drug products, resulting in FDA approval for five NDAs and five supplemental NDAs. Jeannie also formulated domestic and international regulatory strategy for Research, Marketing, QA/QC and Clinical Research Departments, and filed the first company computerized NDA. In 1997, they moved to Solvay as an Assistant Director, where they supervised the department responsible for investigational and marketed products in CNS, Cardiovascular, Gastrointestinal and Women Health Therapeutics, and acted as a global project team lead providing regulatory strategy for clinical, preclinical and technical requirements for new NDAs. Jeannie then joined Novartis Ophthalmology Group in 1998 as a Senior Regulatory Affairs Manager, where they supervised the department responsible for product registration and regulatory submissions for 80 NDAs, ANDAs and INDs, developed and executed global regulatory strategy, and successfully negotiated with FDA regarding Phase 3 protocol requirements resulting in two priority NDA approvals. In 2003, they moved to NuPharmx as Director of Clinical/Regulatory Affairs, where they were responsible for clinical and regulatory project management for a novel inhaled drug delivery system, collected, analyzed and summarized clinical data for submission to regulatory agencies for product approvals, and fulfilled US regulatory, clinical and compliance responsibilities associated with medical device and drugs used for the collection and processing of blood products. In 2006, they joined Rivers Edge as Director of Clinical/Regulatory Affairs, where they were responsible for regulatory, project management, clinical and compliance responsibilities for manufacturing and distribution of 100 prescription products (cough/cold, dermatology, vitamins), package insert and labeling content development for ANDA and marketed products, and contract negotiation and performance management of external contractors including manufacturing facilities, CROs and development partners for compliance to Federal and State regulations and applicable SOPs. In 2009, they joined Emory University as Senior Clinical Research Finance Manager, where they analyzed financial aspects of NIH/Industry sponsored clinical trials for financial and resource feasibility and prepared financial statements, and negotiated budgets of $2M to $5M with industry for clinical trials. Jeannie then joined Macopharma as Director of Regulatory Affairs, where they were responsible for project execution including protocol and case report design, site initiation, study monitoring and date management for multicenter medical device protocols, and collected, analyzed and summarized clinical data for submission to regulatory agencies for product approvals for four 510k medical devices. In 2013, they moved to Baxalta as Regulatory Affairs Manager, where they were a global Regulatory Affairs expert managing three eCTD BLA submissions incorporating technology transfer and commissioning and qualification of new manufacturing facilities for plasma derived products, supervised a team of 6 to 10 individuals responsible for preparation of regulatory documents, and implemented global regulatory strategy to ensure operation plan met submissions timelines. In 2016, they joined Syneos Health Clinical Solutions as Executive Director of Regulatory Strategy and Consulting, where they had line management and program delivery responsibility for US Regulatory team which provided strategic regulatory support for small and midsized pharmaceutical clients, and handled approximately 24 pre-IND meetings and original IND submissions in both 2020 and 2021 with 100% acceptances rate by US FDA. In 2022, they joined Ashvattha Therapeutics, Inc. as Head of Regulatory Affairs.

Jeannie Skinner has a diverse educational background, having earned a Master of Business Administration (M.B.A.) from Montclair State University in 1988, a Master's Degree in Microbiological Sciences and Immunology from Fairleigh Dickinson University in 1981, and a Bachelor's Degree in Clinical Laboratory Science/Medical Technology/Technologist from Rutgers University in 1978.