With over twenty years of experience working for top ten multinational pharmaceutical companies, serving as the Global Head of Regulatory Affairs and Asia-Pacific Head of Regulatory Affairs; formerly a Vice President at a leading domestic listed group, fully responsible for overseas registration projects. Possesses extensive corporate consulting experience, providing clients with efficient clinical development strategies and registration registration strategies.
Proficient in domestic and international registration regulations and guidelines, specializing in the formulation and execution of registration strategies for the United States, Europe, and the Asia-Pacific region. Possesses extensive practical experience in regulatory requirements and registration strategies for chemical drugs, biologics, vaccines, generic drugs, biosimilars, herbal medicines (Chinese patent medicines), and medical devices in various countries and regions. Led a team to complete US FDA application projects, with more than twenty US IND applications in the past three years alone, many of which have received Fast Track, Breakthrough, and Orphan Drug Designation certifications; there is also a major BLA combined NDA application project.
Hosted on-site audits and certifications by various advanced regulatory agencies (such as FDA, EMA, Singapore HSA), covering GMP, GCP, GDP, and QMS inspections, with extensive experience in audit preparation and response.