as a biotechnologist with phd in Biology, i can offer:
6 years of scientific expertise in particular solid scientific knowledge in Cancer Research and strong Analytical Skills with ability to analyze complex projects and provide scientific input to it
almost 4 years of regulatory expertise as a consequence of Pharmaceutical Industry experience in Regulatory Affairs projects management across medical products life-cycle
interpersonal and Communication Skills that ensure effective team-work among cross-functional stakeholders (eemea, eeu, us) in developing solutions and delivering high-quality results in Compliance with international requirements (young Investigator award, munich 2009)
with “right first time” approach, day-to-day work with MS Project, i would bring practice in Planning, coordinating and delivering projects in timely manner through close collaboration with cross-functional stakeholders. this experience broadens my ability to work independently and in a team environment, along with ability for multi-tasking.
i am very excited and i believe i could contribute to the projects from Clinical Development up to market product maturity.
i remain at your disposal for any further information you may require.
Submission Development Lead - Regulatory Affairs Consultant
Since May 2015
Clinical Regulatory Affairs AssociateJanuary 2015 --- May 2015
Clinical Global Regulatory Affairs ConsultantJuly 2013 --- January 2015
Assistant du corps intermédiareSeptember 2007 --- June 2012
Analytical thinkingAttention to detailCollaborationCommunicativeCompetitivenessCreative thinkingCritical thinkingEfficiencyIndependenceInterest in knowledgeProblem solvingResult OrientedSelf-discipline
Biochemistry Cell biology R&D Scientific writingAnalysisAntibodiesBiological Drug DevelopmentBiologyBiotechnologieBiotechnologyCancerCancer ResearchCell biologyCell CultureClinical DevelopmentClinical operationsClinical researchClinical study reportsClinical trial managementClinical trialsCommunication SkillsContinuous ImprovementCross-functional team leadershipDatabasesDNADNA extractionDatabase design and maintenanceDesign of Experiments (DOE) Drug DevelopmentDrug DiscoveryDrug regulatory authoritiesDrug substanceseCTDELISAElectrophoresisEnglishEnzyme AssaysEnzyme-linked immunosorbent assay (ELISA)ExperimentationGel ElectrophoresisGene therapyGenetic polymorphismGeneticsGenomicsImmunoassaysImmunoprecipitationImmunologyIn VitroInfectious diseasesInflammationInternational Project ManagementKnowledge of the drug development processLaboratoryLaboratory SkillsLaboratory study designLaboratory TechniquesLaboratory testingLife SciencesLifesciencesmanagementMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMolecular & Cellular Biologymolecular biologyMolecular DiagnosticsMolecular geneticsMS ProjectMSDNew Drug Application (NDA)next generation sequencingOncologoncologyOperations ManagementOutlookOutsourcingPCRPeptidesPharmaceutical IndustryPharmaceutical ResearchPharmaceutical SciencesPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Pre-clinical researchPreclinical developmentPresentation SkillsPresentationsProblem SolvingProduct developmentProject CoordinationProject ManagementProject PlanningProject Portfolio ManagementPublic SpeakingPurificationqPCRreal-time PCRRegulatory affairsRegulatory RequirementsRegulatory StrategiesRegulatory submissionsResearchRisk AssessmentRT-PCRRNA isolationscienceScientific CommunicationsScientific methodologyScientific WritingSDS-PAGESearch literature on clinical trialsStandard Operating Procedure (SOP)Start-upsStrategic PlanningTeachingTeamworkTechnical reportsTestingTechnology transferTrainingTranslationTroubleshootingUnderstanding of regulatory guidelinesUnderstand levels of research evidenceVaccinesWestern Blotting
Skills and Expertise
Analytical skills Analyze data Guide students Interpret data Molecular Diagnostics Search literature on clinical trials Technology research Use content management systemsAdjust processes Analyze data/information to determine potential relationships.Approve consent documentsAssemble regulatory applications