Specialist, Regulatory Affairs

Principal Duties and Responsibilities (General Summary, essential functions
and authorities, etc.)
主要工作职责（基本概况，主要功能，权限等）
法规事务专员由其直线经理监督管理。法规事务专员负责多个法规事务项目的计划、执行和交付，以实现公司重大目标。法规事务专员负责在直线经理的监督管理下计划并执行所分配项目的注册工作；负责协调不同跨职能部门之间的工作，包括研发、生产、质量、医学事务、临床、法务以及其他职能部门，以满足项目注册之需要。本职位要求具备相应的法规和产品知识、一定的协调能力、沟通能力与执行能力，这些都会直接影响业务部门的运营结果。
RA Specialist is under the supervision from their line manager. They will be
responsible for planning, execution, and delivery of multiple RA projects to
achieve significant company goals. RA Specialist plan and execute the
registration activities for assigned projects under their line manager’s
supervision. They coordinate activities of various cross-functional departments
including research