职位描述

1. Implement RA Department procedures.

执行 RA 部门规章。

2. Ensure each project is effectively completed within scheduled timeframe.

确保每个项目在预定时间内有效完成。

3. Maintain good relationship with the government and pay attention to the

changes of regulatory laws，regulations and guidelines.

与政府保持良好关系，关注注册法律、法规或指导原则变化。

4. Follow internal and Client’s SOPs/polices

遵守内部和客户的 SOPs/政策。

Responsibilities

工作职责

1. Perform product registration activities in regulatory authorities.

在监管机构的框架下执行产品注册相关法规活动。

2. Collect and retrieve the required documents.

搜集检索所需文件。

3. Be responsible for the compiling and binding of the regulatory dossiers.

负责注册资料的编辑和装订。

4. Performing the regulatory submission for products registration

application.

进行产品注册申请的注册提交。

5. Be responsible for the routine visit to regulatory authorities for following

up the technical review or sample test.

负责定期拜访监管机构，跟进技术审评。

6. Establishment of the specific project file and archiving files management.

制订具体的注册申报文件并进行归档管理。