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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

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 Certification
  • Yoga Teacher 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