Kai Shih Er

Background

About Kai Shih Er

Regulatory compliance experience in setting up a global processes and framework for global SOPs and ensuring regional documentations and processes are in alignment and in place across 4 regions (North America, Europe, Japan and APAC). Set up KPIs and metrics for business performance and compliance monitoring at global level.Experience in small molecules CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs covering therapeutic areas of HIV, respiratory, oncology and antibody drug conjugate (ADC). Supported registration of MAAs and NDAs for new chemical entities (NCEs), led responses’ authoring and review for CMC questions, contributed to regulatory strategies for post approval variations, supported routine license renewals and annual reports.Experience in project management by leading cross-functional projects to create and improve processes for regulatory compliance, risk mitigation and work efficiency.Experience in managing diverse teams and stakeholders from different functions such as manufacturing site, technical SME, quality control, quality assurance, contract manufacturer, supply chain and from different regions covering North America, Europe, Japan and APAC.Over 3 years experience as a team lead managing team resources to support key submission activities and ensured regulatory submission and approval timeline were align with project strategy. Developed and coached team members by providing guidance on regulatory activities, achieving their stretch goal and next competency level.Able to communicate both orally and in writing in Chinese (Native speaker), Japanese (intermediate level), Malay (intermediate level) and Cantonese (intermediate level).