Product Regulatory Affairs Manager
安迪苏生命科学制品(上海)有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:贸易/进出口 制药/生物工程
职位信息
- 发布日期:2016-12-12
- 工作地点:上海
- 招聘人数:1人
- 工作经验:5-7年经验
- 学历要求:本科
- 语言要求:英语 精通
- 职位月薪:12000-25000/月
- 职位类别:药品生产/质量管理 药品注册
职位描述
职位描述:
Job Description:
Product Regulatory Affairs Manager
Reporting and location
Report to: TBD
Located in Shanghai
Functional contacts
? Global regulatory affairs team
? ALS sales and technical team
? HQ technical and R&D team
? Authorities/analytical labs/institutes/academies/universities, etc.
Main responsibilities
? Report timely the related regulatory update and/or the promulgation of new regulations.
? Responsible for the registration of new products and the renewal of current products.
? Coordinate the trials for the product registration with internal & external stakeholders.
? Deal with all registration-related issues from the customers, suppliers or authorities.
? Follow up the annual audit of MOA and communicate closely with the relevant authorities.
? Support the registration of BANC-manufactured AT88 outside of China so as to better serve the export business from China.
? Communicate with the industry Standard Committee so as to involve the modification of the product standard.
Qualifications
? Bachelor degree or above in chemical, pharmaceutical major, quality control or production management;
? 5 years (or above) industrial experiences in QA or QC or supplier management, a regulatory affair experiences will be appreciated;
? Good English and Good communication is a “must”;
? Could work under high pressure and a teamwork player.
举报
分享
Job Description:
Product Regulatory Affairs Manager
Reporting and location
Report to: TBD
Located in Shanghai
Functional contacts
? Global regulatory affairs team
? ALS sales and technical team
? HQ technical and R&D team
? Authorities/analytical labs/institutes/academies/universities, etc.
Main responsibilities
? Report timely the related regulatory update and/or the promulgation of new regulations.
? Responsible for the registration of new products and the renewal of current products.
? Coordinate the trials for the product registration with internal & external stakeholders.
? Deal with all registration-related issues from the customers, suppliers or authorities.
? Follow up the annual audit of MOA and communicate closely with the relevant authorities.
? Support the registration of BANC-manufactured AT88 outside of China so as to better serve the export business from China.
? Communicate with the industry Standard Committee so as to involve the modification of the product standard.
Qualifications
? Bachelor degree or above in chemical, pharmaceutical major, quality control or production management;
? 5 years (or above) industrial experiences in QA or QC or supplier management, a regulatory affair experiences will be appreciated;
? Good English and Good communication is a “must”;
? Could work under high pressure and a teamwork player.
职能类别: 药品生产/质量管理 药品注册
关键字: regulatory registration quality manager chemistry
公司介绍
安迪苏公司是一家总部位于巴黎的跨国公司,其业务范围覆盖全球120多个国家或地区,属于全球营养性饲料添加剂领域的领先者,以专业生产罗迪美、固体和液体蛋氨酸、麦可维、维生素、罗酶宝酶制剂系列产品为主。
联系方式
- 公司地址:上班地址:浦东新区芳甸路1155号1003-1008室