BrightOwl Loader Loading

Summary

dears,
.
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.

Experiences

Current Experience

  • Submission Development Lead - Regulatory Affairs Consultant


    Since May 2015

Past Experience

  • Clinical Regulatory Affairs Associate

    January 2015 --- May 2015

  • Clinical Global Regulatory Affairs Consultant

    July 2013 --- January 2015

  • Assistant du corps intermédiare

    September 2007 --- June 2012

Personality

Self Assessment :
Analytical thinkingAttention to detailCollaborationCommunicativeCompetitivenessCreative thinkingCritical thinkingEfficiencyIndependenceInterest in knowledgeProblem solvingResult OrientedSelf-discipline

Knowledge

Self Assessment :
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

Self Assessment :
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

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Polish
Native
French
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
    Yes, 0 to 2 days per week
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • No

Similar Candidates

Other Candidates in Belgium

Other similar Candidates in this location (country / city)

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like