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Summary

I am a freelance Regulatory Affairs Consultant.

Graduate as Industrial Pharmacist, I have:

  • 15 years experience in CMC (redaction & strategical decision for chemical and biological products),
  • 4 years in Quality Assurance (acting as QP),
  • 4 years in pharmacovigilance (acting as EU-QPPV) and
  • 3 years in clinical trials.

Experiences

Current Experience

  • Freelance Regulatory Affairs Consultant
    Since February 2016

Past Experience

  • Senior Regulatory Affairs Associate Lasne, Belgium
    October 2015 --- January 2016

  • Regulatory Affairs Manager Manage, Belgique
    December 2010 --- September 2015

    Responsible of all Regulatory Affairs tasks (worldwide).

    Managing a team of 6 people.

  • EU-QPPV Manage, Belgique
    September 2012 --- June 2015

  • Vaccine Clinical Trials Manager Louvain-la-Neuve, Ottignies-Louvain-la-Neuve, Belgique
    May 2007 --- November 2010

  • Vaccine CMC Manager Louvain-la-Neuve, Ottignies-Louvain-la-Neuve, Belgique
    March 2004 --- April 2007

  • CMC Project Manager Braine-l'Alleud, Belgique
    July 1999 --- March 2004

  • Regulatory Affairs Export Support Puurs, Belgique
    August 1998 --- July 1999

Skills and Expertise

Self Assessment :
Build CMC development planCoordinate CMC-activitiesPrepare CMC source documents Prepare CMC source documents related to clinical trial applicationChemistry Manufacturing and Controls (CMC) activitiesRepresent CMC team Represent the CMC team in the cross-functional development teamResponsibility for the coordination of CMC-activitiesSelect and manage contractors executing the CMC – Chemistry action Create SOPsAdjust processes Adverse event reportingAssess adverse reactionsAssign activitiesCoachDevelop regulatory strategyMaintain Quality Management System (QMS)Prepare regulatory documentsRegulatory submissionsSolve problems

Education

  • Registered Medical Information in Pharmaceutical Sciences from Training year in 2011
  • Registered QPPV in Pharmaceutical Sciences from Training year in 2011
  • Registered Qualified Person (Industrial Pharmacist) in Pharmaceutical Sciences from Training year in 1998
  • Pharmacist in Pharmaceutical Sciences from Univeristé Libre de Bruxelles in 1997

Training and Certification

  • xEVMPD in 2012 Certification
  • EudraVigilance in 2011 Certification

Languages

BrightOwl Assessment:
Self Assessment:
French
Native
English
Professional Proficiency
Dutch
Professional Proficiency

Work Preferences

  • Work From Home:
    Yes, 0 to 5 days per week
  • International:
    No

Area / Region

Obaix, Pont-à-Celles, Belgique

Others

Driving License
  • Yes