Principal, Regulatory Center of Excellence
Joe Lamendola, over a 30 year regulatory career, is responsible for 30+ approvals across 10+ therapeutic areas. With hundreds, if not thousands, of agency interactions under his belt, Joe provides clients with the insights, relationships, and credibility needed to bring drugs to patients quicker.
Core competencies include: Regulatory Strategy, Operations & Policy, Alliance Management, PDUFA, Labeling & Promotion
Prior to joining YourEncore, Joe served as the US VP of Regulatory Sciences for Bristol Myers Squibb and VP of Regulatory Affairs with US and global experience for Schering Plough. In this role, Joe was responsible for leading the regulatory strategy for all global programs across the preclinical, clinical and approval stages.
Beyond drug development, Joe is an expert in strategic alliance governance and organization design, having developed the first BMS US regulatory organization.
A key to Joe’s success has been his ability to collaborate across matrixed organizations and maintain a sense of humor throughout the thrills and challenges of drug development.