职位描述:
1. Newproductapplication,renewalandvariationapplicationandensuretheregulatorycompliance(internalandexternal)forallrelativeactivity.2. CommunicationwithHAandfollowupregistrationreviewandtestingprocesstoobtaintheapprovalduly.3. Provideregulatorystrategytobusinesspartnertosupportnewprojectdevelopmentandexistingproductcontinuity.4. Workwithregionalfranchiseteamonregulatorystrategydevelopment,provideinnovativeregulatorysolutions.5. Monitoringexternalregulatoryenvironment,shapebusinessopportunitiesandchallenges.6. Wellmanageregistrationandregulatorydatabase,timelyupdateandmaintaindocumentinagoodmanner.7. OtherharmonizationworkinRAdepartment.学历要求educationlevelrequirement:Bachelororabove,Chemical/Pharmaceutical/biologicalbackgroundispreferred;工作经验workingexperience:Atleast4yearsworkingexperienceinOTCproductregistration,familiarwithCFDAregistrationrequirements.SufficientinEnglishreadingandwriting.FluentITskillsonMicrosoftoffice,Outlookandinternetoperation.
联系我时,请说是在药品信息网医药人才招聘频道看到的,谢谢!





