RA Specialist

1. 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）
I. Registration
注册：
a) Plan: Well know assigned products' registration plan (new/renewal/change/others) and prioritization defined by supervisor; know how to execute the plan by quarter/month/week/day; frequently track the implementation status
计划：充分了解指定产品的注册计划（新注册/延续注册/变更注册/其他注册事项）和主管确定的注册工作优先次序；知道如何按季度/月/周/天执行计划；经常跟踪计划实施状态
b) Strategy: have basic sense on registration pathway, classification, timeline, review preference…
策略：对注册路径、分类、时间表、审查偏好有基本了解……
c) Execute: compile the registration dossier per most updated NMPA requirements; order sample and follow type testing, to meet registration timeline; prepare eRPS submission and complete payment by due; closely track status in CMDE; handle reviewers questions and provide supporting documents per request; complete filling