Regulatory Affairs Specialist
西氏医药包装(中国)有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-06-19
- 工作地点:上海-闵行区
- 招聘人数:若干
- 职位月薪:面议
- 职位类别:政府事务管理 药品注册
职位描述
1. Job Purpose
To support the regulatory activities in China
To support the registration of West’s products and plants in China
To keep abreast of regulatory issues of relevance in China and raise the alerts accordingly
2. Job Responsibilities
Support the registration of West’s products and plants in China
Identify relevant contacts in SFDA, Beijing and Shanghai for medical packaging and devices
Identify SFDA recognized labs and contract fillers which WPS can use
Identify and establish contacts in Packaging Assoc, in major provinces that will be synergistic to West’s lobbying efforts to fulfill regulatory requirements
Prepare and assemble all information required in dossier for submission as stipulated by SFDA
Gather update and translate regulatory requirements and relevant document
Identify regulatory pursuits by competitors
Any other projects assigned by supervisor
3. Job Requirements
Mature, tenacious with good interpersonal skills, willingness to travel
Graduate in related discipline(Science/Pharmacy/Engineering)
At least 3 years working experience in a pharmaceutical or medical services environment
Experience in handing registration of pharmaceutical /medical devices product in China
Bilingual with good oral, written and translation communication skills
公司介绍
2009年,西氏在华建成第一座工厂,坐落于上上海市青浦工业园区内(SQZ)。青浦工厂总占地面积为31590平方米(7.8英亩),其中厂房约占地13390平方米(大约144000平方英尺)。 目前工厂有100多名员工。
西氏青浦工厂有着先进的注塑成型技术以及世界级的洁净生产环境。 这家工厂为静脉输液瓶生产TrimTec 和 InsoCap 密封装置。 这些密封装置可帮助医药公司以满足中国为提高健康医疗服务品质而设计的日渐严格的药物安全标准。 西氏还将这些密闭装置出口到亚洲、欧洲和南美市场。
在德国的施托尔贝格,西氏也在从事TrimTec 和 InsoCap 密闭装置的生产。在亚太地区,西氏还在新加坡建有一座工厂,并在澳大利亚、中国、印度和新加坡设有销售办事处。