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Summary

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.

Experiences

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 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

Personality

Self Assessment :
AdaptabilityCollaborationCommunicativeCuriosityEfficiencyOptimismOrganizationProactivityProblem solvingResponsibilityResult OrientedSelf-confidenceTrustWillingness to compromiseSociabilityService oriented

Knowledge

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

Education

  • 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

Languages

BrightOwl Assessment:
Self Assessment:
Arabic
Native
French
Native
English
Full Proficiency

Area / Region

Dubai - United Arab Emirates

Others

Driving License
  • Yes

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