RA副总监

公司部门: 北京诺诚

工作地点:北京

发布日期:2022-04-24

招聘人数:1人

职位类型:计算机硬件开发

职位描述:

主要职能:

1. 依据国内外注册法规和指导原则制定注册申报策略;

2. 若项目涉及法规未明确的内容,及时咨询,并将咨询结果反馈给项目组;

3. 及时撰写、审核注册资料,使注册资料的形式和内容符合审评审批要求。按计划递交注册资料;

4. 与NMPA/CDE/中检院等机构司沟通注册相关事宜,并信息反馈给项目组,全程陪同注册核查,直至出具核查报告;

5. 动态跟踪审评审批中产品的审评进度,收集发补意见,并将信息及时反馈给项目组,通过会议形成解决方案;

6. 审核发补意见的答复,在规定时间内递交CDE,跟踪审评进度,直至批件获得;

7. 法规解读:根据项目组需求,组织注册法规解读的培训;

8. 负责上市前及上市后注册事务相关工作。

Key Objectives/Deliverables:

1. Formulate registration declaration strategy in accordance with domestic and foreign registration regulations and guidelines;

2. If the project involves the content not clearly defined by the regulations, timely consult and feedback the consulting results to the project team;

3. Write and review the registration materials in time, so that the form and content of the registration materials meet the review and approval requirements. Submit registration materials as scheduled;

4. Communicate with NMPA/CDE/ China National Inspection Institute and other institutions about registration, and feedback information to the project team, accompany the whole process of registration verification, until the issuance of inspection report;

5. Dynamically track the progress of products in review and approval, collect and issue supplementary opinions, and timely feedback the information to the project team, and form solutions through meetings;

6. Review and issue the reply of supplementary opinions, submit it to CDE within the specified time, track the progress of review until the approval is obtained;

7. Interpretation of regulations: organize the training of interpretation of registration regulations according to the requirements of the project team;

8. Responsible for pre-listing and post-listing registration affairs.

任职条件:

岗位要求:

1. 教育背景:医学/药学/生物学本科或以上学历,熟悉医药相关技术和政策法规;

2. 工作经历:5年以上相关工作经验,至少完成过一个产品的全周期注册经历;最好有大分子CMC的经验

3. 具有良好的英语听说读写能力。

Basic Requirements:

1. Education Background: Bachelor degree or above in medicine, pharmacy, or biology, familiar with pharmaceutical related technology, policies and regulations;

2. Work experience: more than 5 years of relevant work experience, at least one complete product registration experience; Biologics CMC experience is preferred.

3. Good English skills in listening, speaking, reading and writing.

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