RA Manager

Department
部门

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

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。

• 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。

• 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。