With over 15 years of experience working in internationally renowned pharmaceutical companies, have a comprehensive understanding of global regulatory affairs and extensive experience in international registration projects, including strategic planning and formulation for submissions, multi-regional simultaneous submissions (ACCESS), etc.
Successfully assisted customers in emerging eCTD regions (such as China, the Gulf region, South Africa, Australia, etc.) to establish eCTD submission strategies and processes. Helped customers achieve successful global and local product launches.