Michelle Hack

A global regulatory affairs director with 25 years of broad experience building and driving strategy in both development and commercial pharmaceutical products, including small molecule, biologic, and therapeutic vaccines. Regulatory expertise spans clinical, CMC, and advertising and promotion. Recent experience includes collaboration with FDA’s Division of Hematologic Malignancies 1, Division of Drug Oncology 1 and Division of Oncology 2. Successfully planned, prepared, and led various meeting requests and briefing packages. Demonstrates excellent leadership, strategic thinking, organizational, time management, and attention to detail skills. A proven self-starter with the ability to thrive in challenging and ever-changing environments, whether in a small or large companies. Strong expertise of IND, CTA, NDA, and BLA applications; Phase 1, 2, and 3 clinical development, life-cycle management, orphan drugs, fast-track applications, BTDR, drug shortage management, partner development, and global health authorities (US, EU, Canada, Japan, and global expansion markets).