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Experiences

Past Experience

  • Manager Regulatory Affairs Pakistan

    September 2005 --- April 2017

Personality

Self Assessment :
AdaptabilityApproachabilityAssertivenessCharmCollaborationCommunicativeCompetitivenessCreative thinkingDiligenceEfficiencyInterest in knowledgeKindnessOptimismResponsibilitySelf-disciplineResult Oriented

Knowledge

Self Assessment :
Biochemistry Cell biology R&D Scientific writingAdverse Events (AE)Allergy and immunologyAntibodiesBioavailabilityBiopharmaceuticalsBiotechnologycGMPClinical trial audits and inspectionsCMC Regulatory AffairsCompliance with regulationsCurrent Good Manufacturing Practice (CGMP)Drug DevelopmentDrug InteractionDrug regulatory authoritiesDrug Safety and PharmacovigilanceDrug substance developmenteCTDEnglishFDAGood Manufacturing Practice (GMP)Healthcare industryICH guidelinesISO 13485Medical DevicesPharmaceutical Industry

Skills and Expertise

Self Assessment :
Adverse event reportingAssess product quality issuesbudgeting of R&D activitiescollaborate in research projects at universitiesCoordinate recallsDesign scientific projects (in biology)Develop ICH/GCP compliant processesInteract with regulatory stakeholderslifescienceManage research projectsManage regulatory activitiesPrepare regulatory documentsPrepare responses to health authority queriesRegulatory documentationRegulatory submissionsSubmit regulatory applicationsWrite papersWriting regulatory documents

Education

  • Master in Biology from University of Arid Agriculture, Rawalpindi Pakistan in 2002

Training and Certification

  • Drugs Interaction in 2008 Training
  • Product Integration and regulatory compliance in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
URDU
Native
Dutch
Elementary Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    Regulatory Affairs Associate Regulatory Affairs Assistant Regulatory Affairs Consultant Regulatory Project Manager Regulatory and Start-Up Specialist Scientific Officer Scientific Writer GMP Coordinator
  • Positions I am NOT interested in:
    Account Manager - Life Sciences Clinical Director Customer Service Representative HR Manager
  • Locations I am interested in:
    Brussels, Belgium Diest, Belgium Hasselt, Belgium Leuven, Belgium Sint-Truiden, Belgium Wavre, Belgium
  • Work From Home:
    Yes, 5 Days
  • Work Regime:
    Permanent position :    100 percent% FTE
  • International:
    Yes

Publications

    Expert has 4 publications (Will be avalible with full profile)

Area / Region

Tienen, Belgium

Others

Driving License
  • Yes

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