Our Team

Ellen has experience in providing nonclinical and clinical research management support to Sponsors regulated by CBER and CDER. She supports the organization of product development source information into clear, comprehensible applications, including Investigational New Drug (IND) applications (Phase I through Phase III), marketing applications (BLA/NDA), abbreviated and biosimilar marketing applications (505b2, ANDA, 351k), Master Files, and amendments and supplements. Ellen has managed numerous marketed products and development programs and has served as the FDA primary contact person for commercial and development products. She has direct experience in regulatory consulting, authoring of regulatory submissions, study coordination, and quality control. Prior to her role with Biologics, Ellen served as Senior Global Regulatory Affairs Consultant at AustinBio Consulting where she gained experience in regulatory project management and project coordination and execution, in addition to the management of several eCTD NDAs, INDs, BLAs, briefing package submissions. Ellen has experience in many different indications including oncology, haematology, cell and gene therapy, vaccines and immunology in clinical trials and has coordinated submissions globally. Ellen has a B.Sc in Chemistry, M.Sc in Regulatory Science from John Hopkins University.