Michelle McGuinness, M.S. — Non-CMC Regulatory Strategy
As an accomplished pharmaceutical leader, Ms. McGuinness has earned a reputation for crafting successful regulatory strategies, obtaining regulatory approvals, driving principles-based compliance initiatives, and providing advice that empowers the business to better understand risk and ensure that smart, informed decisions are made. Ms. McGuinness has broad experience across all the regulatory science disciplines, and is passionate about drug development, especially for rare diseases and unmet medical needs.
Prior to joining NGT, Ms. McGuinness held various positions of increasing responsibility at AstraZeneca Janssen, Veloxis Pharmaceuticals, Mylan, PA Consulting, Octagon Research Solutions (now part of Accenture), Sanofi, Liquent (now part of Parexel) and Ranbaxy Pharmaceuticals Inc. Ms. Mc Guinness has participated in several joint industry-agency initiatives. She was awarded the FDA Commissioner’s Special Citation for her contribution to the HL7 Structured Product Labeling standard & FDA guidance.
- Regulatory strategies, including expedited pathways and orphan drugs
- Driving digital transformation within the regulatory, quality, and compliance space
- Fast track, breakthrough, accelerated approval, rare pediatric disease designation, orphan drug designation, and priority review
- Managing health authority meetings and negotiations
- Creating and enhancing commercial compliance frameworks
