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Marie-Caroline SMADJA

Paris

En résumé

Mes compétences :
Clinical Trial
Europe
Marketing
Regulatory Affairs
Strategy

Entreprises

  • Sanofi - Global Medical Affairs, Scientific reviewer - oncology, diabetes

    Paris 2012 - maintenant Business partner des divisions
    Conseils pour la préparation des matériels promotionnels et non promotionnels ainsi que des événements internationaux pour l oncologie et le diabete.
    Business leader dans le cadre du déploiement mondial d un outil électronique de revue et approbation du matériel.
    Responsable d'un étudiant en contrat d apprentissage

  • Sanofi-aventis US Inc. - Assistant Director, R&D Regulatory Affairs Oncology

    2010 - 2014 Overview
    Provide Régulatory Strategy to support development of Oncology projects (Clinical Trial Application, Scientific Advice, Paediatric plan, Marketing Authorisation Application)

    Accomplishments
    - EMA Scientific Advice
    - Submission of a Marketing Authorisation Application (e-CTD) in Europe;
    - Maintenance of IND and NDA in US
    - Support global registration stratefy for Rest of the world (including preparation of core briefing package, presubmission meeting, questions/answers)
    - Clinical Trial application to support multinationales Phase III pivotal studies (including initial dossier, amendment, responses to Agencis questions)
    - management of First in Man activities

  • Sanofi-aventis R&D - Global Reg Affairs - R&D Reg Affairs EU - Oncology

    2007 - 2010 Overview
    Provide Régulatory Strategy to support development of Oncology projects (Clinical Trial Application, Scientific Advice, Paediatric plan, Marketing Authorisation Application)

    Accomplishments
    - EMA Scientific Advice
    - Submission of a Marketing Authorisation Application (e-CTD) in Europe; Support for MAA/NDA submission in US and Rest of the world (including preparation of core briefing package, slidekit)
    - Clinical Trial application to support multinationales Phase III pivotal studies (including initial dossier, amendment, responses to Agencis questions)

  • Sanofi-aventis france - Regulatory affairs

    Paris 2005 - 2007 Overview
    Agency interactions to support variations (CMC, Safety) to product registered under National proecdure and Mutual Recognition Procedure.
    Validation of promotional material from Regulatory point of view

    Accomplishment
    Submission of extension of indication and line extension for oncology product registered in MRP with France as Reference member States
    Validation of promotional material in support of launch of new indications, extension line for oncology products

  • Hospital - Resident - Pharmacist

    2000 - 2005 Hospital pharmacist in charge of cytotoxic preparation, management of clinical trials (with commercial or non commercial sponsor), nominative dispensation

Formations

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