Michele Dougherty

Background

About Michele Dougherty

Regulatory Affairs Executive with extensive expertise navigating the complex regulatory landscape associated with biotech and pharmaceutical industries. Leverage experience with US FDA’s Office of Biotechnology Products to enable companies to craft cost effective, efficient development programs. Record of improving FDA approval rates for client regulatory submissions by meticulously organizing filings with the appropriate level of detail and data. Known for building, leading and motivating high-performance teams. High-Impact Results:@ Eliquent Life Sciences Led integration of teams from four legacy business units, applying extensive change management.@ DataRevive Reversed declining revenue trend and tripled pipeline value. Developed standardized IND template, decreasing time for a first draft from 8 to 3 weeks. Increased client retention and satisfaction by improving communication regarding issues with IND projects. Decreased employee turnover from 25% to 13%.@ US FDA Initiated project to enhance efficiency associated with biosimilar labeling review. Ensured consistency in review practices for biosimilars. Improved efficiency and decreased inaccuracies by implementing a workload tracking system. Enhanced employee satisfaction by instituting an objective, transparent process for promotions. Facilitated initiative to generate viable new ideas for managing review process. Core Competencies: • CMC Strategy • Quality Assurance • CMC Documentation • Drug Development • GMP Standards • IND Submissions • FDA Regulations • Regulatory Compliance • Biologics / Biotech / Biosimilars • Regulatory Submissions • Risk Assessment • Team Building & Leadership