职位描述:   职责范围   D uties &R esponsibilities  1、为了使产品能及早进入ICH地区市场，负责公司已立项注册申报产品的注册前期工作，协调并跟进项目实施的进度，最终按照法规要求，整理并撰写注册申报相关资料。 InordertomaketheproductstomarketintotheICHregionsasAPIsasearlyaspossible,responsibleforcoordinatingandfollowinguptheprogressoftheprojects,andultimatelycollateanddrafttheapplicationdossiersinaccordancewiththeregulatoryrequirements. 2、负责将通过内部会审的申请材料，按程序及时进行申报并办理相关手续，并做好递交文档的存档、归档工作。 Whentheapplicationdossierpassesthejointreviewexecutedbymultiplydepartments,responsibleforthetimelysubmissionofdocumentsfollowingrelatedadministrativeprocedures,andthenmakesthesubmitteddocumentsarchived. 3、跟踪药品注册进度。对于审评当局对材料提出的疑问并需要补充资料的情况，要及时反馈公司并询问相关部门，以寻求最合适的解决方案，确保在规定时限内做出回复，使注册申请能够顺利获得批准。 Tracktheregistrationprogress.Oncetheauthorityraisessomequestionsontheapplicationandasksforadditionalinformation,RAshouldmaketimelytransmissiontorelevantdepartmentsanddiscusestofindthemostsuitablesolution.Topromotetheapprovaloftheapplication,makeensurethattherespondishandedupwithintheprescribedtimelimit. 4、通过多种途径掌握ICH地区管理当局的药品注册政策和法规信息动态，并与公司内部相关人员共享信息，避免因政策变化或滞后注册给企业造成经济损失。 ObtainmoreinformationofdrugregulatorypolicyinICHregionsthroughavarietyofwaysdynamically,andthensharetheinformationwithrelevantdepartmentstoavoideconomiclosstocompanyduetothepolicychanges. 5、及时更新汇总产品的注册信息，并向各部门提供相关的支持信息。 Updatethesummaryofproductregistrationstatustimelyandproviderelevantsupportinformationtovariousdepartments. 6、完成部门领导分配或授权进行的其他任务。 Responsibleonothertasksallocatedorentrustedbydepartmentmanager.     资格与经验要求  QualificationandExperience     ·   本科以上学历，药学或相关专业    ·   Bachelordegreeorabovelevel,withmajorofpharmacyorrelated    ·   3 年以上药品注册经验    ·   Minimumoneyeardrugregistrationexperience         主要技能要求      KeyCompetenciesRequired     ·   熟悉药品企业注册流程    ·   Familiarwithdrugregistrationprocedure    ·   良好的沟通协调能力    ·   Goodcommunicationskill    ·   熟练使用英语    ·   GoodatEnglishreading,writing
联系时，请记得是在“job669人才”看到的！