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Summary

i am Doctor in Pharmacy (pharm.d) with a post graduate diploma in biopharmaceutical industry (residency in Pharmacy). eighteen years of professional experience in Life Sciences/biopharmaceutical industry including 12 years in global Regulatory Affairs in various setting (national regulatory agency, small biotechs, gsk biologicals) and 6 years in quality/Project Management/Hospital/R&D. my strengh is to have an integrated knowledge of a Product Development or life cycle management in an international/ multicultural environment from regulatory and product quality global perpectives. i am working at gsk Vaccines for nearly 8 years. my current responsibilities as global product quality are to provide end to end strategic quality and cmc support for my vaccine portfolio in commercial phase. i also spent 6.5 years within the global Regulatory Affairs group (clinical regulatory) in gsk Vaccines (life cycle and early development) and previously worked 3 years as Regulatory Affairs manager in santen SAS (former novagali pharma) where i covered Clinical Development and Marketing authorisation activities (centralised/orphan) for both eu & us regions. i have also ce marked Medical Device. i have successfully worked in projects from phase 1 up to Phase 3 and in products in life cycle and had interactions with a number of Health authorities including european Medicine agency (EMA), ansm (formerly afssaps (French agency)), us FDA, bgtd, medicines and Healthcare products regulatory agency in united kingdom (mhra), paul erhlich institute in germany (pei). interpersonal skills: - adaptive and flexible - strong professional performer - high level of Energy/enthusiastic - reliable and accurate - team player and mentor - high integrity and transparency level - rapid and deep thinker/global thinker - ability to learn fast in new aeras

Experiences

Current Experience

  • Global Product Quality manager


    Since September 2014

Past Experience

  • Clinical regulatory Affairs manager

    March 2008 --- August 2014

  • Regulatory Affairs Manager

    April 2005 --- February 2008

  • Assessor Import/export

    June 2005 --- October 2005

  • Assessor Viral safety

    November 2002 --- May 2005

  • Clinical Research Coordinator

    May 2001 --- October 2002

  • Resident in Pharmacy

    October 2001 --- April 2002
    Research and development Biochemistry (edouard herriot)

  • Resident in Pharmacy

    May 2000 --- October 2000
    parenteral Nutrition for premature babies work under laminar flow Toxicology

  • Resident in Pharmacy

    November 1999 --- April 2000
    Clinical trials management Pharmacy Hospital management Toxicology

Personality

Self Assessment :
AdaptabilityAnalytical thinkingFlexibilityProblem solvingSociabilityInnovative thinkingStrategic thinkingInterest in knowledgeCommunicativeCuriosity

Knowledge

LinkedIn Assessment :
Regulatory affairsRegulatory Strategy DevelopmentRegulatory ComplianceRegulatory submissionsRegulatory RequirementsOphthalmologyOrphan DrugsBiotechnology IndustryLife SciencesRegulatory AgenciesPharmaceutical IndustryProject ManagementVaccinesProduct developmentMatrix LeadershipLeadershipCross-functional CollaborationsClinical DevelopmentClinical trialsCMC Regulatory AffairsTechnical WritingQuality AssuranceMedical DevicesPediatric OphthalmologyFDABusiness StrategyCE markingGMPGCPLabellingCTDEMAHospital PharmacyInternational EnvironmentQuality by DesignProduct QualityClinical ExcellenceResearchStandards CompliancePatient SafetyPeer ReviewsmanagementNew Business DevelopmentNegotiationInternational RelationsBusiness DevelopmentEuropean UnionAnalysisValidationViral Clearance

Education

  • Post doc (DU) in Blood products and plasma from Université Pierre et Marie Curie (Paris VI) in 2004
  • Pharm D, residency Pharmacy in Biomedical and Pharmaceutical industry from Université Claude Bernard Lyon 1 in 2003
  • Master's degree in from IMIS (IGS Lyon) - School of management and marketing of Health industry in 2002
  • Pharmacy in from Université d'Auvergne (Clermont-Ferrand I) in 1999

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Full Proficiency

Work Preferences

  • Positions I am interested in:
    Regulatory Affairs Manager Regulatory Project Manager Director Regulatory Affairs Regulatory and Start-Up Specialist
  • Locations I am interested in:
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Area / Region

Brussels, Belgium

Others

Driving License
  • No

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