Darlene Vickers

A Regulatory Affairs leader with a record of successful guiding development and execution of CMC regulatory strategies, identifying risks and mitigation / contingency plans for project-related CMC regulatory issues, while leading highly effective submission processes. In-depth CMC regulatory expertise from early pre-clinical through late-stage (commercial registration submissions, inspection preparation, CMC SME). Expert at uniting diverse individuals from various departments into cohesive teams and leading to achieve aggressive submission and compliance goals. Master’s degree in Regulatory Affairs and Health Policy.