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Current Experience

  • Regulatory Affairs Manager Trainee
    Since March 2015
    -Preparation, revision and follow-up of submissions of Clinical Trial Applications to local, national Competent Authorities (Poland, Belgium) according to national laws, regulatory guidelelines and requierements -Preparation, revision and follow-up of the submission of Orphan Drug designation to EMA -Preparation, writing and update of Standard Operating Procedure and other regulatory file documentation (IMPD) to ensure compliance with Regulatory requirements

Past Experience

  • Managing Director of my own company (SPRL RecoNaisSens)
    December 2009 --- July 2014
    - Managed an operational team of 4 to 5 people & improved the day to day running to be more effcient - Organized and managed the schedules of personal and appointments of clients - Analyzed the figures & presented the accounts and the balance sheets (assets-liabilities) - Prospected new customers and new partners (commercial development) for both healthcare services and distribution of cosmetic products

  • Clinical Project Manager, Department of Global Medical Operations & Clinical Affairs
    June 2008 --- February 2009
    - Managed a multicentric Phase IV clinical trial (epidemiology and biomarkers in Rheumatoid Arthritis patients) - Organized meetings, budget and timing of the clinical trial in partnership with the clinical operations team - Selected Investigators and managed contracts with hospital/clinical sites and external laboratories - Supervised a Clinical Trial Assistant (CTA) for the preparation and revision of Sponsor Master File (SMF) and Investigator Master File (IMF)

  • Director Associate of Quality Control, Quality Control Department
    October 2006 --- May 2008
    -Tracked the drug development process, quality systems, and scientific issues in cell and gene therapy -Approved the QC releases of all the batches of final Drug Substances or Drug Products (to be manufactured) -Approved the QC releases of all the raw materials (to be used in GMP processes for DS and/or DP) -Reviewed the protocols and reports related to the stability studies and protein characterization, analytical validation studies according to ICH Q2 and equipment validation studies (IQ, OQ, PQ)

  • Clinical Project Manager, Clinical Research Department
    January 2004 --- September 2006
    -Managed a Phase II clinical trial (Belgium) and Phase III (international multi-centric) clinical trials for GSK project ( HBV vaccine) -Prepared, reviewed, completed, and updated regulatory documents, files and applications for clinical trials and marketing approvals including IB, leaflet, clinical protocol, IMPD, e-CTD (CMC submission sections) -Submitted CTAs to Ethics Committees and to Health Authorities; Reviewed/approved analytical DS&DP -Dealt with Data management and Biostatistics of clinical trials in collaboration with several CROs (e.g., Cropha, 4Clinics, and SGS) -Supervised CRAs: Wrote clinical SOPs for monitoring and checked CRFs, IB, leaflet in compliance with GCP

  • R&D Project Manager, Cell Culture Department
    September 1998 --- December 2003
    -Developed Cell (CHO, VERO) Culture processes in bioreactor -Reviewed and approved protocols (SOPs) related to Mammalian and bacterial Working Cell Banks -Participated in development of Cell ( keratinocytes and fibroblasts) culture on flasks and Skin substitute -Reviewed and approved protocols related to routine manufacture in GLP environment (at the beginning of the UMH spin-off) and in GMP environment (at the new industrial facilities of Seneffe)


LinkedIn Assessment :
Microsoft Officegestion de projetMicrosoft ExcelPlanification stratVenteMicrosoft WordPlannification Etudes CliniquesGestion de BudgetEcoute du clientLife CoachingMassage thMmassage de relaxationSoins de la peauBien-


  • Ph'D (or Doctorate) in BioSciences from Université de Liège in 1994
  • Master's degree in Chemistry from Facultés universitaires 'Notre-Dame de la Paix' in 1990
  • Bachelor of Applied Science (B.A.Sc.) in Chemistry from Facultés universitaires 'Notre-Dame de la Paix' in 1988

Area / Region

La Bruyere, Belgium


Driving License
  • No