Job functions include, but are not limited to the following:
工作职责包括但不限于:
• Write, compile, and review registration dossiers to ensure the completeness and accuracy;
撰写,汇总并审阅申报注册资料,确保申报资料的完整性和准确性;
• Continuously improve template documents used by development, manufacturing, and quality departments to streamline writing and compiling CMC dossiers;
持续改进用于研发,生产和质量部门的文件模板以简化写作流程并撰写CMC文档;
• Maintain/archive regulatory documentations。
整理归档申报资料。
• Assist to RA manager for liaison with Regulatory Authorities and other related agencies。
帮助经理与监管或其他机构进行联络。