MEDICAL

1. NewDrugandInlineProductsRegistrationPlanning&;ImplementingforthetherapeuticareaofAIproducts.
2. Setupnewproductregistrationplan,preparetheregulatorysubmissionsforregistrationofnewproducts,variationsandrenewalstomarketedproductsandclinicaltrialapplications,whererequired
3. Criticallyanalysisdatapackagesforregulatorycomplianceandidentifydiscrepanciesindatapresentedandrequestadditionaldata
4. Developanoverallperspectiveplanofregistrationprojects
5. Prepareresponsestodeficiencylettersandensurethattheseandotherdatarequirementsaresubmittedtoregulatoryagencieswithinthestipulatedoragreedtimeframes
6. MaintainandupdatetheLocalProductDocument(labeling)inaccordancewithrelevantregulationsandPPGSOPs
7. MaintainanuptodateknowledgeoftherelevantlegislationinChina
8. Maintainadequateproductknowledgetoensurepromptandprofessionalresponsestoqueriesrelatingtocompanyproducts
9. Provideregulatoryadvicetocompanypersonnelasrequired
10. PartnerwiththeglobalregulatoryandclinicaldevelopmentteaminGIP/GEPBUsfornewproductsdevelopmentstrategyandinlineproductsstrategy.
11. PartnerwithPGSandPharmaSciencesfortheimplementationChinaGMP,ChinesePharmacopeia(CHP)andotherChinaregulatoryrequirementsinPGSsites.
12. PartnerwithPGSforsupplystrategytoavoidsupplyissueduetositechanges
13. Provideregulatoryinputsfortheapprovalofpromotionalmaterialsfollowingapplicableregulatoryrequirement,Pfizerpolicies,procedures,andpractices
14. Build-upRelationshipswithBothRelevantGovernmentAgenciesandCorporateSupportingTeams,EnsureCompliancewiththeRegulationsandExpediteApprovals
15. Wellunderstandregulationsandbuildupaplatformtocommunicatewithofficials
16. Providenecessaryandtimelysupportstopolicyteamforallthepolicyadvocacyactivities
17. Efficientlyusecompanyresourcetoenhancetheworkingrelationshipwithrelevantgovernmentagenciesandbuildingstrongcompanyimage
18. Activelycollectinformationandmonitorthechangeofregulatoryenvironment;
19. Strengthentheliaisonwithcorporatesupportteamsviavarioustoolsorcommunicationchannelsduringdailyoperation
20. EnsuringRegulatoryCompliance
21. EnsuretimelycommunicatetherequirementofCHPandotherChinaregulationstoPGSQOandGCMCtofacilitatetheimplementofCHPandotherregulationsinPGSsites
22. Ensurelocalprocessinplaceforthetimelysubmissionofallthequalityandsafetyrelevantvariationsincludinglabelingsafetyupdateandspecification/manufactureprocesschange
23. SpecialProjects
24. BerequiredtoparticipateonspecialprojectsfortheRegulatoryAffairsGroup
25. MarketingSupport
26. AttendRegulatoryAffairsDepartment,newproductdevelopment,Medicalandotherinternalmeetingsasrequired
27. Providearesourceorsupportsforothersectionsofthecompanyforspecifiedtherapeuticareas
28. PeopleManagement&;TeamWorkSpirit
29. Demonstrateandinfluencetheteamonleadershipbehaviorandcorevalueindailywork,intermsofcoachinganddevelopingpeople;information/bestexpertisesharing;positiveandconstructivewayofcommunication(frank,honest,friendlyetc)
30. EnsureeffectivecommunicationsbetweenRegulatoryAffairsDepartmentandotherfunctionalteamswithincompany.
31. PersonalDevelopment
32. CompletethePfizerPRESafetyReportingProcess:Overviewtrainingmoduleinthesettimeframe
33. Attendandactivelyparticipateinpersonaldevelopmentcoursesasrequired
34. Attendtraininginspecifictherapeuticareasasrequired.
35. LeadRegulatoryAffairs,ClinicaldevelopmentandMedicalDepartmentprojectsandworkshops