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注册专员/主管/经理

工作地点:北京         所属类型:GCS-Formulation         发布时间:2020-11-12

岗位描述:

1. 在高级总监领导下执行药品注册申报工作;

Under the leadership of the senior director, perform drug registration and application work;

2. 根据注册要求独立编写、审核、申报中美制剂注册文件;

Independently compile, review and declare the registration documents of Sino-US preparations in accordance with the registration requirements;

3. 关注国内外法规动态,阅读相关内容并理解其中心思想;负责跟进和解读药品相关法规政策和要求,与FDA、NMPA等保持良好沟通;向公司内部人员传递法规动态等相关信息;

Pay attention to domestic and foreign regulatory trends, read relevant content and understand its central ideas; be responsible for following up and interpreting drug-related regulations, policies and requirements, and maintaining good communication with FDA, NMPA, etc.; conveying regulatory trends and other related information to the company's internal personnel;

4. 相关药品及文献的检索翻译、相关数据库的查询工作,妥善保管药品注册文件;

Retrieval and translation of related drugs and literature, query related databases, and properly keep drug registration documents;

5. 负责规划产品注册申请的时间与计划,及时完整地整理和准备注册申请文件资料,确保资料及信息符合申请国相关政策法规要求;

Responsible for planning the time and plan of product registration application, sorting out and preparing registration application documents and materials in a timely and complete manner, and ensuring that the materials and information meet the requirements of relevant policies and regulations of the applicant country;

6. 上级指派的其他工作。

Other duties as assigned by superior.

任职资格:

1. 制剂、分析、药学或其他相关专业本科及以上学历;

Formulation, Analysis, Pharmacy or other relevant education background, bachelor degree and above;

2. 3年以上药品注册相关经验, 有505b(2)注册经验者优先;

More than 3 years of drug registration related experience, 505b(2) registration experience is preferred;

3. 熟悉国内外药品注册法规、GMP指南及FDA/NMPA指导原则;

Familiar with domestic and foreign drug registration regulations, GMP guidelines, FDA and NMPA guidelines;

4. 具有良好的英语沟通和文献资料的查阅能力。

Have good English communication and literature review ability.