Senior Director, GRA CMC Pharmaceuticals Development Portfolio Lead

4 weeks ago

Étreux, Hauts-de-France, United States Takeda Pharmaceuticals Full time

pAtTakeda,weareaforward-looking,world-classR&Dorganizationthatunlocksinnovationanddeliverstransformativetherapiestopatients.ByfocusingR&Deffortsonfourtherapeuticareasandothertargetedinvestments,wepushtheboundariesofwhatispossibleinordertobringlife-changingtherapiestopatientsworldwide./ppThispositionisakeyleadershiprolewithinourRegulatoryAffairsCMCteam,responsibleforestablishingcollaborationwithGlobalCMCteamsandleadershipthroughnetworksandenablingCMCregulatoryteam'ssuccessinmeetinggoals/objectives.Thesuccessfulcandidatewillinfluencechangingregulationsandguidancedocuments,interfacewithoutsideregulatoryagenciesandtradeassociations,andactasanadvisor/liaisontoseniormanagementtoplan,evaluate,andrecommendimplementationstrategy./ppAspartoftheRegulatoryAffairsCMCteam,youwillreporttotheExecutiveDirectorandHead,CMCRegulatoryAffairs–Pharmaceuticals.YouwillleadtheEarlyDevelopmentPharmaceuticalsGRACMCregulatoryteaminthedevelopmentandimplementationofglobalCMCregulatorystrategiesduringdevelopment,commercialization,andpost-approvalLCMstages./ppTheidealcandidatewillhaveastrongunderstandingofscientific,regulatory,andbusinessissuesandbeabletoensurethatregulatoryfilingsareofhighqualityandrightfirsttime.Youwillmaintainup-to-dateknowledgeandexpertiseofrelevantCMCandqualityguidelinesandregulationsandestablishmechanismstocommunicatethemtorelevantstakeholders,therebydrivingprospectiveandproactiveimplementation./ppGlobally,youwillinfluenceandbegenerallyconsideredakeyopinionleaderandresourcewithinTakedaandexternallywithstakeholdersinHAandinIndustry.YouwillberesponsiblefordemonstratingTakedaleadershipbehaviorsandservingasamemberoftheGRA-CMCPharmaceuticalsLeadershipteam,givinginputtokeystrategic,portfolio,humancapital,andfinancialdecisions./ppYouwillprovideleadershipofGRACMCPharmaceuticals–inconjunctionwithdirectreports,manageresources,establishaCMCRAstrategy,andcollaboratewithstakeholdersinglobalRegCMCandacrosstheenterprisetodeliveragainstthem.Inconjunctionwithmembersoftheteam,youwilldevelophigh-qualityclinical,commercialization,andLCMsubmissions,usingproactiveregulatoryCMCstrategiesandsubmitthemasplanned./ppYouwillbuildandmanagerelationshipsthroughactivepartneringwithkeyinternal(GRA,GRACMC,PharmaceuticalSciences,GMS,GQetc.)andexternalstakeholders(Healthauthorities,Industrycounterparts/associations,academia).RelationshipmanagementandconstructivepartneringwithHealthAuthoritiesandrelevantindustryorganizationstodriveTakedapositionandinfluencescientificapproachandthoughtprocesstoCMCtopics./ppYouwillensureteameffectivenessinworkingacrossaverycomplexmatrixenvironmentinGRAwithCMCRAprojectleadsandotherGRAsub-functions,asneededtoensureeffectivestrategiesaredevelopedandprojectexecutionisontarget.Youwillbuildandmaintaincommunicationstrategyandplatformforallstaffacrosstheorganization.Responsiblefortimelydisseminationofregulations,guidelines,anddatatostaffandstakeholdersviateamsitesorintranet.Activelyengageandinfluenceorganizationtothinkproactivelyandutilizescienceandrisk-basedapproachtoproductdevelopmentandLCMactivities./ppYouwillcontributetocreatingandcommunicatinganemploymentcultureandvalueswhichattract,retain,anddevelopthemosteffectivepeople.EnsurecompliancewithallapplicableTakedaSOPs,localandinternationalregulations,andindustrybest-practice.Represents,asrequired,theregulatoryfunctionintheevaluationofnewproductopportunitiesinternallyandexternally.LeadsorplaysakeyroleontherelevantinternalTakedagovernancecommittees./ppbRequirements:/b/pulliAdvancedDegreeorPhDinLifeSciences,PharmacyorMedicines,orrelateddiscipline./liliMinimumof15yearsofexperiencewithinregulatoryagenciesorthePharmaceuticalIndustryincludingsignificantleadershipexperienceinRegulatorySciences./liliSignificantunderstandingandtrackrecordindealingwithinternationalregulationsandpoliciessettingprocessesofmajorregulatoryagencies(e.g.USFDA,EU,PMDA,NMPA,WHO)./liliActivelyengagedinmajorindustryassociations(e.g.CPC,EFPIA,BIO,PhRMA,CASSS,PDA,ISPE,DIA)andjointregulator/industryinitiatives(e.g.ICH)./liliStrongcommunication,collaboration,negotiation,problem-solving,andinterpersonalskills.Hasaproventrackrecordofworkingacrossregulator/industryboundariestofindcommonsolutionsanddrivepositiveimpactandbenefitsforpatients./liliLanguages:FluentinEnglish,additionallanguagesdesirable./liliHighorganizationawareness(e.g.interrelationshipofdepartments,businesspriorities),includingsignificantexperienceworkingcross-functionallyandinteams./li/ul

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