Li-chun Tsou MBA, PhD

Brought 17-year biotechnology experiences in leading drug-device combination products from concept to launch; initiated global commercialization of pre-filled syringes based autoinjectors; implemented strategies to establish new product portfolios; integrated 3V (increasing Visibility, increasing Velocity, and decreasing Variability) methodologies to support new product launches; Supported cutting edge device technology for global initiatives on patient-centric therapeutics; Led cross-functional team located in multiple countries including Clinical Research, Operation, CMC Regulatory, and Quality to ensure clinical readiness, regulatory submission, and manufacturing robustness of devices launch; Achieved prompt product commercialization through shoulder-to-shoulder engineering to meet both short-term and long-term pipeline needs; Accomplished two successful regulatory submissions in 2013 through regulatory agency interaction and authoring container closure system integrity and process validation for biological drug products including one to treat melanoma cancer, and the other to prevent cervical cancer. Served as subject matter expert to design control and implemented medical device and combination product trainings to achieve quality compliance and regulatory requirement in 21-CFR-210, -211, - 820, -600, ISO-13485 and ISO-14971 Risk Management, EN 62366 Human Factors, ISO-10993, and ISO-11608 requirements, as well to institute corrective and preventive actions, and to track change control and maintain design history file for FDA and EMA on-site inspection and post market surveillance.