RA Director/Manager/Specialist
上海仕璞企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：民营公司
- 公司行业：专业服务(咨询、人力资源、财会) 制药/生物工程
职位信息
- 发布日期：2013-01-09
- 工作地点：北京
- 招聘人数：若干
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：普通话精通
英语精通 - 职位类别：药品注册
职位描述
Accountabilities:
§ Focus on PM projects, communicate with HQ of company to request registration documents and samples.
§ Work independently to prepare and submit the registration dossier for new products, IDL renewal and variation application.
§ Follow up and push QC test, CDE review & SFDA approval process to obtain the approval duly.
§ Registration dossier management.
§ Maintain internal DRA system.
§ Implement DRA sop.
§ Other harmonization work in DRA
Skills & Competencies Requirement:
§ Bachelors degree,Masters degree (e.g. MBA, MSc);Pharmaceuticals,Chemistry,Biology
§ More than 5 years import drug registration working experiences
§ Good relationship & experience with relevant authorities is preferred;
§ Must be extremely detail oriented, well organized, and work well under pressure. Strong learning ability;
§ Good personalities with team spirit;
§ Interpersonal and communication skills are also required.
§ Focus on PM projects, communicate with HQ of company to request registration documents and samples.
§ Work independently to prepare and submit the registration dossier for new products, IDL renewal and variation application.
§ Follow up and push QC test, CDE review & SFDA approval process to obtain the approval duly.
§ Registration dossier management.
§ Maintain internal DRA system.
§ Implement DRA sop.
§ Other harmonization work in DRA
Skills & Competencies Requirement:
§ Bachelors degree,Masters degree (e.g. MBA, MSc);Pharmaceuticals,Chemistry,Biology
§ More than 5 years import drug registration working experiences
§ Good relationship & experience with relevant authorities is preferred;
§ Must be extremely detail oriented, well organized, and work well under pressure. Strong learning ability;
§ Good personalities with team spirit;
§ Interpersonal and communication skills are also required.
公司介绍
上海仕璞企业管理咨询有限公司 诚聘
专业提供医药行业咨询服务
简历投递：nickeyzhu@searchpple.com
地址：上海浦东张杨路828号华都大厦3F(2 4 6 9 世纪大道地铁站12号口3分钟）
专业提供医药行业咨询服务
简历投递：nickeyzhu@searchpple.com
地址：上海浦东张杨路828号华都大厦3F(2 4 6 9 世纪大道地铁站12号口3分钟）
联系方式
- Email：nickeyzhu@searchpple.com