- Regulatory policy development and analysis
- Strategic regulatory guidance
- Previous experience in regulatory and science policy development
Katie McCarthy brings more than 15 years of policy experience to Greenleaf, where she serves as Senior Vice President of Regulatory Affairs. Katie specializes in scientific and regulatory issues affecting pharmaceutical and biotechnology companies.
In her role at Greenleaf, Katie focuses on a variety of topics, including: domestic and global biosimilars policy, drug safety, implementation of the FDARA & 21st Century Cures.
Katie’s background is primarily in drug development and policies affecting healthcare professionals and the patient communities they serve. She has been extensively involved in projects that span a number of therapeutic areas, from preclinical safety assessment to clinical safety and efficacy. Her work includes emerging electronic prescribing efforts, privacy and health information exchange, and related bioethical considerations in the clinical development process.
Katie holds a Master’s of Public Health from George Washington University and a B.A. from St. Cloud State University, Minnesota.