上海 [切换城市] 上海招聘上海生物/制药/医疗器械招聘上海药品注册招聘

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.

职能类别: 药品生产/质量管理 药品注册

关键字: regulatory registration quality manager chemistry

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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