REGULATORY AFFAIRS PHARMACIST
Since October 2015
- provide on-going regulatory support to the Regulatory Affairs senior manager to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- represent the regulatory function at Manufacturing site on cross functional and project teams and provide strategic regulatory advice.
- compile regulatory dossiers in accordance with national requirements.
- manage relationship with external regulatory authorities as required.
- manage and prepare renewals and variations submissions to the ministry of Health
- maintain close contacts with the local operating companies' (loc’s) to ensure shared objectives are achieved
- coordinate the registration activities within area of responsibility to ensure deadlines are met
- Provide on-going regulatory support to the Regulatory Affairs Senior Manager to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- Represent the Regulatory function at manufacturing site on cross functional and project teams and provide strategic regulatory advice.
- Compile regulatory dossiers in accordance with national requirements.
- Manage relationship with external regulatory authorities as required.
- Manage and prepare renewals and variations submissions to the ministry of health
- Maintain close contacts with the Local Operating Companies' (LOC’s) to ensure shared objectives are achieved
- Coordinate the registration activities within area of responsibility to ensure deadlines are met
Since May 2015
- update of Packaging and artworks materials through system ( agile , harmony ) according to local regulation and gsk processes :
- coordinate activities associated with the labelling and artworks management
- manage strategies and plans for labelling and artworks changes
- use regulatory knowledge to provide support and strategic input in structuring labelling components, and ensures that labelling materials meet regulatory and company requirements, and timelines.
- Update of packaging and Artworks materials through system ( Agile , Harmony ) according to local regulation and GSK processes :
- Coordinate activities associated with the Labelling and Artworks Management
- Manage strategies and plans for Labelling and Artworks Changes
- Use regulatory knowledge to provide support and strategic input in structuring labelling components, and ensures that labelling materials meet regulatory and company requirements, and timelines.
- Deploy the artwork Management System ‘Harmony’ (Project Manager and Site Implementation Lead )
OPERATIONAL QUALITY PHARMACIST
Since May 2015
- coordinate internal audits and inspections
- Qualified Person for batch release
- manage and deploy Quality Systems (artworks management, customers complaints, capa, deviation management)
- manage and deploy gps system (5S, operator standard work, Problem Solving, and kpi)
- manage and deploy ‘anti-counterfeiting’ process
- deploy the artwork management system ‘harmony’
- participate in the deployment of the ‘data integrity’ process
- develop and review sops and guidelines
- Coordinate internal audits and inspections
- Qualified person for Batch Release
- Manage and deploy Quality Systems (Artworks Management, Customers complaints, CAPA, Deviation management)
- Manage and deploy GPS System (5S, Operator Standard Work, Problem Solving, and KPI)
- Manage and deploy ‘Anti-counterfeiting’ process
- Deploy the artwork Management System ‘Harmony’
- Participate in the deployment of the ‘Data integrity’ Process
- Develop and review SOPs and Guidelines
AdaptabilityAnalytical thinkingAttention to detailCommunicativeCoordinationCreative thinkingCuriosityEfficiencyFlexibilityIndependenceInnovative thinkingInterest in knowledgeKindnessOrganizationProactivityProblem solvingReaction to stress
Biochemistry Biostatistics Scientific writingAnalytical Method ValidationBiopharmaceuticalsBPFBusiness IntelligenceCAPAcGMPChange ManagementChange ControlCMCCMC Regulatory AffairsCommunication SkillsCompliance with regulationsContinuous ImprovementDrug regulatory authoritiesEnglishGMPGXPHealthcare industryICH guidelinesISO 9000ISO 9001It skillsManufacturingMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft WordOutlookPackagingPharmaceutical IndustryPharmaceutical ManufacturingPharmacistsPharmaceuticalsPharmacyPresentation SkillsProblem SolvingProcess improvementProject ManagementProject PlanningQuality Assurance (QA)Quality Control (QC)Quality AuditingQuality Management System (QMS)Regulatory ComplianceRegulatory affairs
Skills and Expertise
Analytical skills Build the CMC development plan Control data Create SOPs Develop protocols Interpret dataWriting regulatory documentsWrite statistical reportsWrite documentsVerify dataValidate dataUse laboratory techniquesUse content management systemsUse fluorescence microscopyTranslate protocol into packaging and labeling requirementsTrain StaffTrain on site staffSubmit regulatory applicationsSolve problemsSetup of research equipmentSet-up quality policiesproject managementImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Labeling compliance with local regulationsIdentify risksRegulatory submissionsDevelop regulatory strategyRelease products
Doctor in Pharmacy in Pharmaceutical Sciences from University Of Algiers in 2014
Bachelor in Experimental Science from Technical High School Raid Nahnah in 2008
Training and Certification
Pharmacy Assistant in 2015 Training
JLPT L5 in 2014 Certification