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Pierre SAHAKIAN

LYON

En résumé

Experienced professional in Regulatory Affairs and Drug Development for biotechnology products, Orphan Drugs and Innovative medicinal products.
Main skills include International Regulatory Affairs, Scientific Advice meetings, Clinical Trial Applications, Clinical Operations, Global Project Lead and Management, CRO selection and management, Development Strategies as well as Quality Assurance.

Mes compétences :
Santé
Management
Drug Development
Scientific Advice
Biotechnology
Orphan Drugs
Clinical Trials
Innovation

Entreprises

  • Alizé Pharma - Regulatory Affairs & QA Manager- Drug Development project leader

    2008 - maintenant Regulatory Affairs:
    Preparation and filing of multi-centric Clinical Trials Authorizations/Investigational New Drug dossiers
    Meetings with Health Authorities (EU, US)
    Orphan Drug Designation (EU, US)
    Management of consultants

    Projects Management:
    Development Plan writing (strategy, activities, resources, timelines, budget)
    Preparation and obtaining of grants to support the projects
    Management and support to the project team including medical, CMC and nonclinical (internal and external ressources)
    Clinical operations (documents preparation, contract and budget negotiation, clinical trial material supply etc)
    Project follow-up (timelines, budget...)

    Quality Assurance:
    Set-up of the internal quality assurance system
    Management of QA activities including audits, deviations, agreements review...

  • OPi (EUSA) - Project Manager - Regulatory Affairs

    2004 - 2007 Project Management: Registration of a biologic product in the US and in Europe

    Responsibilities consisted in project team organization, including human resources allocation estimate, budget definition and follow-up, deliverables and timelines definition and project team management
    (US and EU based people from EUSA/OPi, manufacturer based in UK).

    Regulatory Affairs:

    Management of worldwide products registration strategy and postmarketing activities, especially for onco-hematology products (L-asparaginases).
    Close relation with health authorities and local partners.
    Experience in EU/US/Canada and ROW includes MA transfers, renewals, variations (MA file update), IND management (IND amendment, FDA meeting…),ODD, BLA preparation, IND reactivation.

  • BioMérieux - Regulatory Affairs Trainee

    MARCY-L'ETOILE 2003 - 2004 Analysis and compilation of Regulatory bodies’ requirements outside EEA in close relation with subsidiaries and local authorities.
    Comparison between bioMérieux SOPs and ISO standards norms for validation of softwares used in
    In Vitro Diagnostic devices was part of the missions.

Formations

  • IPIL Institut De Pharmacie Industrielle De Lyon

    Lyon 2003 - 2004 Master Degree

  • EM LYON

    Ecully 2003 - 2004 Master Degree

  • Université Lyon 1 Claude Bernard (Lyon)

    Lyon 1997 - 2004 Pharm D

    Pharmacy - Thesis: “Veno-occlusive disease of the liver and chimerism incidence evaluation further to individualization of the posology of the busulfan in pediatric bone marrow transplantation.”

Réseau

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