RA Manager

Department
部门

Regulatory Affairs
注册部
Title
职位

Regulatory Affairs Manager / Sr. Regulatory Affairs Manage
注册经理 / 高级注册经理

Starting Date
任职时间
Direct Report
直线经理

Associate Regulatory Affairs Director/Director
注册副总监/总监

Direct Subordinates
直接下属
N/A
Primary Function
主要职能

Provide regulatory strategy; Implement the submission, follow up until achieving the approval; Support to other functions on regulation affair issues.

制定注册申报策略;递交注册申请资料、跟进注册状态直至批准;为相关部门提供注册法规事务支持。

Major Responsibilities and Duties
主要职责和任务
  • Perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with regulations, guidelines and internal processes.
  • Lead responsible regulatory submissions including prepare and review related registration dossier to ensure dossier completeness and accuracy.
  • Follow up the review status, keep line manager posted of any progress and propose solutions to critical issues before implementation.
  • Lead regulatory related test required, monitor the process of test and help resolve technical issues.
  • Provide regulatory guidance of GMP/GLP/GCP if required to on-site inspection during registration by NMPA.
  • Intelligence: monitor regulatory intelligence news timely and inform project team if any impact.
  • Collect regulatory information of competitors.
  • Maintain/archive all regulatory documentation.
  • Draft internal SOPs and maintain internal share disk.
  • 根据相关法规、指导原则和内部流程的要求,组织、实施所负责产品的注册相关日常工作,在规定时限 内完成注册任务。
  • 组织所负责产品的注册申请,包括相应注册资料的撰写和审核,确保资料的完整性和准确性。
  • 跟进审评动态,及时通知直线经理发现的关键问题并提供建议的解决方案。
  • 组织完成注册检验(跟进检测过程,协助解决技术问题)。
  • 根据 NMPA 要求,为注册过程中研制核查及生产现场检查提供 GMP / GLP / GCP 相关法规指导。
  • 法规信息:密切关注注册相关法规和指导原则的发布/更新,如有影响,及时反馈给项目团队。
  • 收集竞品注册相关信息。
  • 所有注册文件的维护 / 归档。
  • SOP 起草,公共盘维护。
Qualifications
资格要求
  • Over 5-year regulatory affairs experiences in pharmaceutical.
  • Familiar with regulatory regulation, guideline and requirements.
  • Good written and oral communication skills.
  • Cooperative, dedicated and responsible.
  • 5 年以上药品注册经验。
  • 熟悉注册法规、指导原则和要求。
  • 良好的写作、沟通能力。
  • 良好的协作精神,敬业,有责任感。