Senior Director Regulatory Affairs
Senior Director Regulatory Affairs
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Medicines for Malaria Venture (MMV) is the worlds leading product development partnership (PDP) dedicated to discovering developing and delivering affordable and effective antimalarial .
MMV collaborates with government agencies private and public sector partners and clinical centers in malariaendemic regions to bring lifesaving solutions to the people most affected by malaria. Our work is made possible through funding from various sources including government agencies foundations corporations and individuals.
Joinusinourmissiontodefeatmalaria. .
If you are a seasoned regulatory expert with a passion for global health a proven track record of navigating complex regulatory landscapes and a collaborative spirit to drive impactful change we encourage you to apply.
Primary Duties and Responsibilities
RegulatoryLeadership&Intelligence:
- DevelopandexecuteregulatorystrategiesforthedevelopmentapprovalandpostapprovalevidencegenerationofantimalarialdrugsinMMVsportfolioensuringalignmentwithglobalandlocalregulatoryrequirements
- CriticallyassessdevelopmentplansandstudydesignsensuringcompliancewithSRArequirementswhileidentifyingchallenges/gapsandmitigatingtherisks
- LeadorcoleadwithMMVpartnerspreparatoryactivitiesforinteractionswithregulatoryauthoritiesandWHOensuringrobustjustificationfordevelopmentapproachesregistrationandpolicyadoption
- Monitorandinfluencewhenpossibleevolvingregulatorylandscapesandpolicychangesintegratingemergingtrendsinintodevelopmentstrategiesclinicaltrialdesignsandriskmitigationframeworks
RegulatoryImplementation:
- Provideregulatoryleadershipandhandsonexpertisebydraftingcompilingandsubmittingkeyregulatorydocuments()whereMMVisthesponsororeffectivereviewwhenpartnerorganizationisthesponsorensuringalignmentwithprogramobjectivesandMMVsstrategy
- Establishandoverseetheselectionandmanagementofexternalregulatoryconsultancieswhenrequiredensuringexecutionofdeliverables
- AlignMMVsapproacheswithAMAsharmonizationeffortsandtheAfricanUnionsPharmaceuticalManufacturingPlanforAfrica
Stakeholder&TeamEngagement
- BuildandmaintainstrongrelationshipswithglobalregulatoryexpertsindustrypartnersfellowProductDevelopmentPartnership(PDP)organizationsandNGOstostayaheadofevolvingrequirements
- Supportourengagementwithkeyinnovationfunders(forbothR&Dandaccess)toensurethatweshareacommonvisiononoptimalregulatorypathwaysincludingthoseinmalariaendemiccountriestoachievemaximalimpactfornextgenerationproducts
- FostereffectivecommunicationbysharingexpertiseandlearningsacrossprojectteamsatMMVandpartnerorganizations
- LeadbyexampleembracingMMVvaluesmanageanddevelopdirectreport(s)
QualificationsandSkills
EducationandExperience
- PharmDPhDinlifesciencesorrelatedfield
- Morethan10yearsofregulatoryexperiencewithinpharmaceuticalindustryorbiotechwithproventrackrecordofsuccessfuldrugregulatorysubmissionsandinteractionswithglobalhealthauthoritiesinR&.
- Experiencewithstringentregulatoryauthorities(EUand/orUS)isrequiredexperiencewithmalariaendemiccountriesregulatoryauthoritieswouldbehighlyvaluable
- Experienceleadingregulatorystrategiesforearlystageandlatestagedevelopmentprograms.
- Experienceindrugcombinationsdevelopmentpaediatricdevelopmentand/orinfectiousdiseaseswouldbehighlyvaluable
- Experiencewithglobalpublichealthnormativebodies()andWHOprequalificationprocesseswouldbehighlydesirableaswellasexperienceinengagingwithLMICpolicyregulatoryreviewprocesses.
TechnicalSkills
- Bewillingtotakeahandsonapproachtotherole
- Highlyskilledinwritingpresentingleadingmeetingsandinteractingwithteamsexternalstakeholdersandregulatoryagencies
- Abilitytothriveinafastpacedinnovativeenvironmentandmanagemultiplepriorities
- ExcellentknowledgeofdrugdevelopmentandICHGoodClinicalPracticestandards
- Comfortableworkingwithmultiplecomplexpartnershipsandwithcrossfunctionalprojectteams
- FluentinEnglish(oralandwritten);Frenchand/orotherlanguagesisanasset.
- FullyversedinallrelevantITtools
BehaviouralSkills
- Strongleadershipinbothregulatoryandhealthpolicyenvironment
- Excellentverbalandwrittencommunicationskills
- Stronginfluencingandnegotiationsskills
- Demonstrateflexibilitydedicationandproblemsolvingattitude
- Excellentinterpersonalskillswithabilitytointerfacewellwithinternationalorganizationandexternalpartners
- Willingnesstotravelupto10
If you are a driven regulatory leader eager to contribute to global health with a strong track record and ideally experience in malaria drug development and regulation in endemic countries we invite you to bring your expertise to our mission.
Location: Geneva Switzerland
Startingdate: asap
Interested applicants should send their CV and a motivation letter explaining their interest in the position.
MMV is committed to building a talented and diverse workforce selecting candidates based on their skills abilities and experience. We foster an inclusive workplace free from discrimination on the basis of race color religion political beliefs age nationality disability gender or sexual orientation.
Our hybrid working model encourages inoffice collaboration. For candidates residing in Switzerland we expect a minimum of two days per week in the office; for crossborder candidates residing in France at least three days per week. Please note that this is not a remote role and MMV offers relocation support for highly qualified candidates.
For more information about MMVs activities please refer to our website
Nonmandatedrecruitmentagenciesarekindlyrequestedtorefrainfromsubmittingapplications.
Required Experience:
Exec
Employment Type
Full-Time
