[北京]拜耳医药保健

职位：Registration Officer
发布时间：2009-06-17
工作地点：北京
信息来源：北京大学医学部
职位类型：全职
职位描述
拜耳医药保健招聘毕业生(09-06-17)

发布日期：2009-6-17

拜耳医药保健招聘毕业生 拜耳医药保健和中国的渊源可以追朔到二十世纪初期，拜耳早在1936年就开始在上海生产销售阿司匹林。今天的拜耳医药保健在中国已经拥有3000多名雇员，4个业务 群：拜耳先灵医药、保健消费品、糖尿病保健和动物保健。拜耳医药保健作为拜耳集团的子集团是世界领先的医药保健、医疗产品制造企业。 拜耳医药保健在全球是由动物保健、保健消费品、糖尿病保健和拜耳先灵医药共4个部门组成。2007年拜耳医药保健收购先灵，成立拜耳先灵医药部，拜耳先灵医药部包括有四个业务部门：普药业务，影像诊断业务、抗肿瘤/特殊治疗业务、女性健康业务。2006年拜耳医药保健全球销售额达117亿欧元。拜耳医药保健的目标是研究开发、生产和销售用于预防、诊断和治疗疾病的原研产品，拜耳医药保健致力于提高人类及动物的健康水平。目前由于新业务的发展，我们需要招聘以下职位： Registration Officer(注册事务主任) Registration OfficerJob Responsibilities:? Assist for preparation, submission and follow-up for new drug registration application, including ordering dossiers from HQ, Preparing submitting dossiers, following up and solving problems ? Coordinate dossier preparation of CMC, Pre-clinical, and clinical parts, including arranging translation and checking? Responsible for maintaining licenses, covering license renewal, LRL applications and supplementary applications? Coordinate for the lab test for some applications, solve problems and ensure the lab test completed timely and properly ? Build and maintain good relationships with officials and experts of relative authorities; good communication with officials and experts to guarantee smooth registration? Follow up closely with the information of relevant competition products? Collect periodically new relevant laws and regulations from SFDA and CDE website and provide comments? Provide consulting result of relative products and give the correct suggestion to TA manager and relative departments of BHC? Help to do the archiving work within the teamRequirements:? Bachelor degree or above on chemistry, pharmacy, pharmacology, medicine? At least 1-year Regulatory Affairs related experience preferred.? Professional knowledge on Chemistry, Pharmacy, Pharmacology, and clinical trial. ? Be familiar with corresponding regulations and procedures: SFDA regulations and international guideline (ICH, FDA, EMEA)? Chinese writing ability for formal letters? Good negotiation skill? Good communication skill? Good teamwork? Good at written and oral English ? Solid computer skill请谅解：简历投递方式仅为电子邮件投递，不接受其它投递方式。 Email：ariel.liu@ 人力资源部 刘慧 公司地址：北京朝阳区东三环中路7号北京财富中心写字楼A座16层