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Highly motivated individual almost 10 years of experience in Quality & Regulatory CMC supporting marketed products Biotech and Small Molecules. My core values "People First, Do Big, Grow through Changes, Work Fun". Flexibility & Leadership Adaptability to dynamic environment with competing projects, deadlines and unexpected events. Proactive & Positive team player with a customer service approach and solution oriented Problem solving Communicate complex issues in a simple way with Creative & Innovative solutions while being an advocate for compliance. Open-minded Love working in multicultural teams. Win friends. Whatever culture you belong to, the idea is to be sincere towards your fellow workers.


Current Experience

  • Regulatory Affairs Manager
    Since March 2013
    Corporate Headquarter • Develop regulatory strategy on a Global level according to International requirements (including MEA region) to support post-marketing activities • Ensure Compliance to applicable regulations cGMP, ICH and Sanofi SOPs & quality standards. • Identify project gaps and develop alternate strategies and remediation. • Lead, coach and develop teams and creating positive experience and build team capability. • Regulatory intelligence by monitoring emerging trends of industry regulation critical for organization's performance • Participate to Industry and Health Authorities initiatives

Past Experience

  • Quality Assurance Manager
    January 2011 --- February 2013
    • Team management : 4 persons • Product Batch release for Worldwide markets (including MEA region) • QA oversight for cGMP compliance • Provide direction to ensure inspection readiness • Timely completion of investigation and associated CAPAs • Ensure Risk Management, Change Control Process, Annual Product Review and GMP Training • Appropriately challenge the status quo for continuous improvement • CMO Quality Management manufacturing & control according to Quality agreement oversee, manage and coordinate the CMO collaboration • Audit Leader

  • Regulatory site officer
    January 2008 --- December 2010
    • Team management : 4 persons • Products marketed Worldwide (including MEA region) • Act as primary regulatory representative of the manufacturing site. • Ensure strong assessment of all site Change Controls. • Authoring and review of high quality regulatory documentations to support post approval changes, renewals and response to health authorities. • Lead regulatory site objective and insure implementation


Self Assessment :
AdaptabilityCollaborationCommunicativeCuriosityEfficiencyOptimismOrganizationProactivityProblem solvingResponsibilityResult OrientedSelf-confidenceTrustWillingness to compromiseSociabilityService oriented


LinkedIn Assessment :
Regulatory affairsQuality AssuranceCMC Regulatory AffairsmanagementBiotechnologyPharmaceutical IndustrySecteur pharmaceutiqueBPFBiotechnologieAffaires rSOPPharmaceutiquegestion de projetANSMValidationGMPEdqmeCTD

Skills and Expertise

Self Assessment :
Manufacture of GMP batches Create SOPs Assure medical quality Build the CMC development planAdjust processes and methodsAseptic processingAseptic techniquesAssemble regulatory applicationsCoachManage regulatory activitiesaudit


  • course in Biotechnology from ENSTBB Bordeaux INP in 2014
  • Doctor of Pharmacy (Pharm.D.) in Pharmacy from Université Henri Poincaré, Nancy 1 in 2007
  • Master’s Degree in quality assurance and quality control from Paris-Sud University (Paris XI) in 2007
  • Doctor of Pharmacy (Pharm.D.) in Pharmacy from Université d'Alger in 2004


BrightOwl Assessment:
Self Assessment:
Full Proficiency

Area / Region

Dubai - United Arab Emirates


Driving License
  • Yes