Regulatory and Market Access outsourcing strategy, planning and implementationBusiness Development, including creating customised programme solutions, resourcing and pricingExecutive Leadership of Regulatory and Market Access Solution Consultant team across Asia, including oversight of financial performanceGlobal proposal management and approval on new sales opportunitiesDevelopment and delivery of strategic business plan and regional expansion through new initiatives and client… Show more Regulatory and Market Access outsourcing strategy, planning and implementationBusiness Development, including creating customised programme solutions, resourcing and pricingExecutive Leadership of Regulatory and Market Access Solution Consultant team across Asia, including oversight of financial performanceGlobal proposal management and approval on new sales opportunitiesDevelopment and delivery of strategic business plan and regional expansion through new initiatives and client growthFinancial direction of payment schedules, delivery analysis and backlog projectionRegulatory and commercialisation consultation advice to clientsReview and approval of contractual termsClient relationship management on Strategic PartnershipsPartnership metric oversight and analysis Show less

Regulatory outsourcing strategy and planning Business Development, including creating customised programme solutions, resourcing and pricingRegulatory consultation and advice to clientsProposal oversight and approvalLeadership on new sales opportunitiesRegulatory IntelligenceFinancial Oversight, including creation of payment schedules, assessment of financial performance and backlog projectionReview and approval of contractual termsClient relationship management… Show more Regulatory outsourcing strategy and planning Business Development, including creating customised programme solutions, resourcing and pricingRegulatory consultation and advice to clientsProposal oversight and approvalLeadership on new sales opportunitiesRegulatory IntelligenceFinancial Oversight, including creation of payment schedules, assessment of financial performance and backlog projectionReview and approval of contractual termsClient relationship management Mentoring of Programme ManagersPartnership Metric oversight and analysis Show less

Global leadership and oversight of strategic planning for all clinical study startup activities across Biopharmaceutical, Oncology and Medical Device divisionsCreation, management and implementation of startup strategies Oversight of startup intelligence Ownership of startup and quality metrics, including tracking, analysis and reporting Business Development, including developing customised project strategies/timelinesExecutive Leadership as part of Global Clinical Services… Show more Global leadership and oversight of strategic planning for all clinical study startup activities across Biopharmaceutical, Oncology and Medical Device divisionsCreation, management and implementation of startup strategies Oversight of startup intelligence Ownership of startup and quality metrics, including tracking, analysis and reporting Business Development, including developing customised project strategies/timelinesExecutive Leadership as part of Global Clinical Services Management TeamFeasibility – start-up supportRFP Budget preparation and maintenanceStrategic governance committee representation with clientsBid Defence participationEU Legal Representative for ChilternGCP ComplianceProject proposal authoringRegulatory advice to clientsInternal Strategic Initiative Support and LeadershipTrainingManagement of clinical study startup marketing materialsSOP Preparation and Approval Show less

Line and Operational Management of Global Regulatory Affairs TeamLine and Operational Management of Global Medical Writing TeamFinancial Management including preparation of budgets and managing of revenues including ongoing P&L analysisTrainingProject Invoicing and Financial Recognition SOP Preparation and ApprovalBusiness Development SupportRegulatory IntelligenceQuality Metrics AnalysisStudy Start-up respresentative

Line and Operational Management of Global Regulatory Affairs TeamOperational Management of Global Medical Writing TeamFinancial Management including preparation of budgets and managing of revenues including ongoing P&L analysisTrainingProject Invoicing and Financial Recognition SOP Preparation and ApprovalBusiness Development SupportRegulatory IntelligenceStudy Start-up respresentativeLeader Risk Based Monitoring initiative

Line and Operational Management of Global Regulatory Management TeamFinancial Management including preparation of budgets and managing of revenues including ongoing P&L analysisTrainingProject Invoicing and Financial Recognition SOP Preparation and ApprovalBusiness Development SupportRegulatory IntelligenceManagement of Study Start-up Intiative

Project Management Staff AllocationRegulatory Budget and Proposals TrainingBusiness DevelopmentRegulatory submissions (CTAs, CTA-As, MAAs & ODD)Regulatory IntelligenceDrug Release reviewInsurance supportGlobal Head of start up team and leader of new initiative

Project Management Staff AllocationRegulatory Budget and Proposals TrainingBusiness DevelopmentRegulatory submissions (CTAs, CTA-As, MAAs & ODD)Regulatory IntelligenceDrug Release reviewInsurance support

Regulatory Project Management Staff AllocationBudget approval for regulatory projectsBusiness Development SupportLine Management of UK Regulatory StaffRegulatory Advice to ClientsTrainingManagement of office LogisticsAuthoring, reviewing and submitting of CTAs in various global markets Responding to regulatory questions from agenciesRegulatory IntelligenceReview of information for Drug ReleaseGenerating regulatory documents for CTA/MAA submissions… Show more Regulatory Project Management Staff AllocationBudget approval for regulatory projectsBusiness Development SupportLine Management of UK Regulatory StaffRegulatory Advice to ClientsTrainingManagement of office LogisticsAuthoring, reviewing and submitting of CTAs in various global markets Responding to regulatory questions from agenciesRegulatory IntelligenceReview of information for Drug ReleaseGenerating regulatory documents for CTA/MAA submissions Arranging InsuranceReview of Label textProviding training to clinical colleagues Show less

Regulatory Project Management Authoring, reviewing and submitting of CTAs in various global markets Authoring of regulatory project proposalsResponding to regulatory questions from agenciesRegulatory IntelligenceGenerating regulatory documents for CTA/MAA submissions Arranging InsuranceReview of LabellingProviding training to clinical colleaguesTraining

Authoring and submitting Modules 1, 2 and 3 for initial MAAs Renewals in CTD formatSource change, packaging, compliance, active ingredient and manufacturing variations in a number of markets for various products and therapeutic classesResponding to regulatory questions from Agencies/MoHsProject ManagementSubmission of EDMFs and EDMF amendments to Agencies/MoHs CTX submissions Review of Change Controls Maintenance of compliance records (RIFs)Membership of… Show more Authoring and submitting Modules 1, 2 and 3 for initial MAAs Renewals in CTD formatSource change, packaging, compliance, active ingredient and manufacturing variations in a number of markets for various products and therapeutic classesResponding to regulatory questions from Agencies/MoHsProject ManagementSubmission of EDMFs and EDMF amendments to Agencies/MoHs CTX submissions Review of Change Controls Maintenance of compliance records (RIFs)Membership of European Sustainable Compliance Initiative (SCI) Project Team Membership of Global Document Standards, Submission Liaison and CMC Interim Process teams Show less

Filing source transfer variations as part of IMC 95 project in European and African marketsSource change, packaging, compliance, active ingredient and manufacturing variations in a number of markets for various products and therapeutic classesMAAs/Renewal applications in a number of marketsDevelopment and maintanance of 5 year renewal planThird party liaisonsCreating and maintaining compliance records for various products Assisting in the divestments of drug products to… Show more Filing source transfer variations as part of IMC 95 project in European and African marketsSource change, packaging, compliance, active ingredient and manufacturing variations in a number of markets for various products and therapeutic classesMAAs/Renewal applications in a number of marketsDevelopment and maintanance of 5 year renewal planThird party liaisonsCreating and maintaining compliance records for various products Assisting in the divestments of drug products to third parties by handling regulatory requirementsAuthoring Expert Reports/Statements and tabular summaries Show less

Supporting integration and update of technical documentation to support re-classification of heritage drug products to OTC statusAuthoring MAAs/renewalsRegulatory Intelligence Converting existing MAAs to electronic modules in EDMS systemResponding to Regulatory Questions received from agenciesCompilation of non-clinical and clinical sections for MAA submissionsAuthoring expert reports

Authoring CMC sections for MAAs/renewals in a number of global countries (including Europe, Africa and Asia)Creating and filing variations (source change/manufacturing) in various marketsResponding to Regulatory Questions received from agenciesConverting existing MAAs to electronic modules in EDMSCreating and updating regulatory compliance documentsAuthoring Expert Reports/Statements and tabular summaries