Cara Weyker, MBA

Cara provides regulatory affairs; chemistry, manufacturing, and controls (CMC) and quality assurance support to the healthcare industry worldwide with over 30 years of experience in both large and small start-up companies. Cara’s experience includes interpretation of GxP and ICH standards and regulations to establish, implement and improve regulatory-compliant systems and procedures. Cara has led the development, implementation and continuous improvement of quality systems covering both research and development and commercial activities. She is experienced in the preparation, tracking, and submission of U.S., European, and Canadian regulatory documents and in the lifecycle management of BLA, IND, and NDA programs. She also led CMC regulatory strategies for new and late-stage development programs as well as postapproval changes to maintain regulatory compliance. Cara also has experience in working and leading analytical development laboratory covering early phase development through to technology transfer to manufacturing plant. Cara has an MBA from Keller Graduate School of Management and a B.A in Chemistry from Ripon College.