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Summary

i'm an experienced professional in biologicals Research and development, with over 20 years experience in industry and over 8 in Regulatory Affairs. i'm interested in Innovation, and bringing my experience to a small company or biotech with an exciting portfolio and strong people values.

Experiences

Current Experience

  • Director Regulatory Affairs


    Since April 2007
    responsible for market authorisation Applications and life cycle management for new Vaccines worldwide Responsible for market authorisation applications and life cycle management for new vaccines worldwide

Past Experience

  • Project Manager - Vaccine development

    January 2001 --- March 2007
    global lead of new vaccine development, from Preclinical to post-licensure

  • Senior Scientist - cancer vaccines research

    September 1996 --- December 2000

Personality

Self Assessment :
CommunicativeEfficiencyFlexibilityInnovative thinkingStrategic thinkingResponsibility

Knowledge

Self Assessment :
R&D Scientific writingBiological Drug DevelopmentBiomedical SciencesBiopharmaceuticalsClinical DevelopmentClinical researchClinical Study DesignCoachingCompliance with regulationseCTDEMAInfectious diseasesNutritionpeople managementRegulatory affairsRegulatory RequirementsRegulatory StrategiesRegulatory submissionsScientific WritingStudy protocolsTeam LeadershipUnderstanding of regulatory guidelinesVaccines
LinkedIn Assessment :
VaccinesLife SciencesRegulatory StrategyRegulatory submissionsRegulatory affairsRegulatory RequirementsClinical DevelopmentInfectious diseasesClinical trialsoncologyCancerBiotechnologyLifesciencesPharmacovigilanceStrategyDrug DevelopmentPharmaceutical IndustryImmunologyGCPBiopharmaceuticalsGMP

Skills and Expertise

Self Assessment :
RegulatoryvaccinesR&D

Education

  • PhD in Bioinformatics from Facultes Universitaires Namur in 1996
  • Master in Biology from ULg in 1988
  • Bachelor in Science from Université libre de Bruxelles in 1986

Training and Certification

  • Nutritionist in 0000 Certification
  • Yoga Teacher in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
Spanish
Native
French
Native
CATALAN
Elementary Proficiency

Work Preferences

  • Notice Period:
    13 weeks
  • Positions I am interested in:
    Director Regulatory Affairs R&D Director Medical Director vaccines
  • Locations I am interested in:
    Belgium Spain Switzerland UK
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Brussels, Belgium

Others

Driving License
  • Yes

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