Global Submission Lead
MSI Pharma
Location: Brussels,Belgium EngagementStatus: Contract until December 2026 Overview Wearepartneredwitha leadingglobalbiopharmaceuticalorganisation andareseekinganexperienced GlobalSubmissionLead todrivethestrategicplanning,coordination,andexecutionofglobalregulatorysubmissions.Thisisahighlyvisiblerolerequiringstrongprojectleadership,cross-functionalcollaboration,anddeepunderstandingofregulatorysubmissionprocesses. Key Responsibilities Leadthe strategicplanningandexecutionofglobalregulatorysubmissions Drivecross-functionalsubmissionteamstodeliveronagreedtimelines Proactivelyidentifyrisks,resolveissues,andmanagecompetingpriorities Ownsubmissiongovernanceincluding meetingfacilitation,actiontracking,andreporting Ensurealignmentacrossstakeholdersandmaintainclear,effectivecommunication Contributetocontinuousimprovementinitiativesandbestpractices Supportonboardingandtrainingonsubmissionandprojectmanagementprocesses Requirements Hard Skills Strongknowledgeof globalregulatoryprocesses and CommonTechnicalDocument(CTD) Proven projectmanagementexpertise withindrugdevelopment Experienceusingprojecttools(e.g.SharePoint,OfficeTimeline,Integrateorsimilar) Understandingofregulatorysubmissionplanningandexecution Excellentwrittenandverbal Englishcommunication Soft Skills Strongleadershipandstakeholdermanagementcapabilities Confidentdecision-makingincomplex,fast-pacedenvironments Excellentorganisation,prioritisation,andself-management Proactive,solution-oriented,andresilientmindset Collaborativeteamplayerwithculturalawarenessandflexibility Experience & Education 5+years’experienceina pharmaceutical,biotech,orCROenvironment Backgroundinacross-functionalorregulatoryrole Degreeinscience,engineering,orahealth-relateddisciplinepreferred PMI/PRINCE2certification isanadvantage #J-18808-Ljbffr
Vacancy posted 22 hours ago
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