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Experiences

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 -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 science)" rel="nofollow">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)

Knowledge

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

Education

  • 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

Others

Driving License
  • No

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