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.
Freelance Regulatory Affairs Consultant
Since February 2016
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
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
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