Pamela Fitzpatrick Ms

Pamela Fitzpatrick has over 30 years of experience in various roles within the pharmaceutical and healthcare industries. Pamela began their career at Quest Diagnostics, where they served as both a Manager of Environmental Health and Safety and a Manager of Quality Assurance. In these positions, they developed and implemented facility-wide programs and managed all related activities. Pamela also conducted audits and inspections and was heavily involved in external audits.

From there, Pamela joined OSI Pharmaceuticals as a Manager of Regulatory Affairs. Pamela coordinated US and international regulatory filing activities and provided guidance and support to project and cross-functional teams. Pamela also collected and disseminated regulatory intelligence and played a key role in regulatory updates and safety filings.

Subsequently, Pamela worked at MESOBLAST, INC as a Senior Manager of Regulatory Affairs. In this role, they oversaw all regulatory IND activities and ensured compliance throughout the product lifecycle. Pamela also reviewed and approved regulatory documentation and provided regulatory expertise.

Currently, Pamela is the Director of Regulatory Affairs Clinical at Amneal Pharmaceuticals. In this position, they provide comprehensive regulatory support and leadership for drug development programs. Pamela serves as the regulatory lead and CDER liaison for developmental products across various therapeutic areas.

Pamela Fitzpatrick has an MBA in Total Quality Management from Dowling College, which they earned from 1998-2003. Pamela also holds an MS in Biology and a BS in Biology from Adelphi University, although the specific years of completion were not provided.