职位描述：
主要工作职责 & 行为 / 任务
注册法规事务助理为医学部注册法规事务经理和注册法规事务团队提供行政支持支持，确保注册法规事务团队的有效运作；同时，注册法规事务助理将负责协调注册法规事务团队的项目。
基本要求
-为注册法规事务团队提供行政支持，以确保注册法规事务团队的有效运作
-协助注册法规事务团队对产品注册资料进行文档管理以确保注册文档资料的妥善保管
-协助注册法规事务团队注册样品/临床试验样品海关清关工作以确保样品及时从海关放行
-协助注册法规事务团队传递相关注册文件/样品到相关政府机构
-协助注册法规事务团对SFDA批文进行文档管理
-较强的沟通能力，团队合作精神
-较强的文档资料管理能力，计划能力
-药学专业,专科或以上学历
-良好的英文书面及口头表达能力
-良好的计算机Word, excel, PowerPoint技能
KEY RESULT AREAS & JOB ACTIVITIES /TASKS
The Regulatory Affairs Assistant (RAA) provides administration support to the Manager of Regulatory affairs and team of regulatory affairs in medical department. The Regulatory Affairs Assistant (RAA) is responsible for ensuring efficient and effective administrative operations within Regulatory Affairs team. In addition to administrative duties, the Assistant is also assigned to coordinate special projects or tasks and will contribute to the achievement of Regulatory Affairs team’s Objectives.
Provide administrative support to ensure the efficient and effective operation in regulatory affairs team
-Assist Regulatory affairs team in archiving regulatory documentations
-Assist RA team in handling customs clearance of registration samples and clinical supplies
-Assist RA team in delivering relevant documents& samples to regulatory agency
-Assist RA team in managing SFDA approval documents
BACKGROUND REQUIREMENTS
-Good communication and team cooperation skill.
-Good documentation archiving and planning skill
-College degree or above in pharmaceuticals
-Excellence in Word, excel, PowerPoint
-Good English skill both in written and oral
|
