Head of Regulatory Affairs Consultancy focused on Regulatory Strategy, Regulatory operations, Regulatory compliance (GXP), Project Management, Medical Writing, Quality Assurance Regulatory consultant/FDA liaison for >100 pharmaceutical and biotechnology companies, Board of Directors, Investment firmsAdvisor for multiple global development programs leading to successful IND, NDA, MAA, NADA filings. Senior Consulting Partner, SciMed Partners, Inc.Acting Head/ Sr/Vice President of Regulatory Affairs for multiple biotech/pharma companies including publicly traded firms. Regulatory advisor for >100 Investigational New Drug (IND), global clinical trial applications (CTX), including first-in-human products, multinational Phase 2/3 clinical trials. Regulatory advisor for late-stage negotiations for marketing authorizations with positive outcomes.Development of global regulatory strategies and product development plans for several programs. Therapeutic Areas included Oncology, Pain, Autoimmune diseases, Antimicrobial/Antiviral, DiabetesStrategy consultant for several oncology programs (DOP1, DOP2, DHP) including immuno-oncology programs from pre-IND phase through registration.Strategic consulting for health authority meetings (pre-IND, EOP1 (Project Optimus), EOP2, Type C, pre-NDA, EU Scientific Advice, oral explanation) with successful outcomes. Due-diligence to support partnering activities (Pharma, venture funding)Experienced with successful breakthrough designations, fast track designations, orphan drug designations, SPA negotiations, comparability protocol negotiationsQuality, pharmacology/toxicology, clinical amendments, Investigator’s Brochure, clinical study protocols and reports, Preparation and review of Module 2 NDA summaries

Head of Regulatory affairs for pipeline focused on biosimilar monoclonal antibodies products. Regulatory lead for investor and partner due diligence activities which culminated in successful round of financing. Regulatory lead in successful health authority interactions.