Direcotr of RA

¥61k - ¥80k pm
Permanent
Guangzhou Shi
17 Jun 2022
BBBH819433

Prepare and support clinical trial and product license applications for customers

Responsibility:

1.Prepare and support clinical trial and product license applications for customers (for mammalian products). This includes the following:

为客户(哺乳动物产品)准备并支持临床试验和产品许可申请。这包括以下内容:

2. Write / review CMC sections;

撰写/审阅CMC部分;

3. Prepare briefing documents for agency meetings;

为机构会议准备简报文件;

4.Attend customer meetings and project team meetings;

参加客户会议和项目组会议;

5.Devise and maintain regulatory project plans in line with best practice recommendations;

根据最佳实践建议设计和维护监管项目计划;

6.Update functional leads and maintain transparency of information across regulatory function.

更新职能领导,保持整个监管职能部门信息的透明度

7.Provide regulatory support and advice to internal customers in line with defined Regulatory plans and in response to ad-hoc questions.

根据规定的监管计划,针对特殊问题,向内部客户提供监管支持和建议

8. Provide regulatory assessments and approvals for change controls and deviations.

为变更控制和偏差提供监管评估和批准

9.Support site specific regulatory documents.

.支持特定于现场的监管文件。

Requirements:

1.Bachelor or above in biology/biochemistry major;

生物学/生物化学专业本科及以上学历;

2. Substantial experience in preparing and authoring CMC sections for early phase applications and license applications.

在为早期申请和许可证申请准备和编写CMC章节方面具有丰富经验

3.Good communication skills

良好的沟通技巧

4.Ensures delivery excellence for his/her own goals

确保为自己的目标提供卓越的交付

Team Leader | M3S Recruitment
86 21 8033 3012 | lqin@morganmckinley.com