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Baptiste BARBIER

Paris

En résumé

As a future graduate (Pharm.D.) in October 2014, I am looking for a position as a Regulatory Affairs Junior Associate. I am currently a Regulatory Site Officer at Sanofi near Dijon (France). I am in charge of type I & II variation dossiers, Module 3 of the CTD, renewals of marketing authorizations and site transfer management. In October 2014, I will have had sixteen months’ practical experience in this domain.

I am personally very interested in the international context of Regulatory Affairs. I am young, dynamic and mobile. I am strongly self-motivated and I like working in a team. Working in a Regulatory Affairs Department will give me the opportunity to develop my skills in the company. It will also satisfy my deep interest in a foreign culture and add an international dimension to my experience in my home country, France.

Entreprises

  • Sanofi - Regulatory Site Officer Apprentice

    Paris 2013 - maintenant • Management, preparation and ensuring of the timely completion CMC-related regulatory
    submissions (local and international)
    • Regulatory representative for the maintenance of drug products
    • Reviewing technical reports and summary documents (chemistry, manufacturing and
    analytical controls) to ensure adherence to regulatory guidelines, strategies, and commitments
    • Evaluation of change control requests - Regulatory input on Change Control proposals
    • Redaction and submission of timely responses to questions from Health Authorities

  • Sanofi - Trainee in Regulatory Affairs/Quality Systems

    Paris 2013 - 2013 • Submission of new applications and variations - CMC/CTD
    • Change control management
    • Follow-up & drafting of variations (Types I & II) about transfer of injectable products
    • Relationships with Global Regulatory Affairs (GRA), with other Regulatory Affairs
    Officers (RSO) and with Industrial Regulatory Compliance (IRC)
    • Responses to questions from Health Authorities

  • Centre Hospitalo-Universitaire CHU - Dijon - Trainee in a Cardiovascular Surgery Unit

    2013 - 2013 • Talking about treatments with doctors & professors
    • Follow-up of operations in a surgical ward
    • Preparation of patients’ treatments
    • Talks with patients about their disease and complications with treatments
    • Reports on pharmacovigilance issues

  • Centre Hospitalo-Universitaire CHU - Dijon - Trainee in a Mycology Laboratory

    2012 - 2012 • Diagnostics & interpretation in fungal infections and reporting the results (to clinical
    units)
    • Memorandum ’Setting up of Quality Accreditation for the Mycology Analysis Laboratory
    of the Teaching Hospital in Dijon’

Formations

  • Université De Bourgogne Faculté de Pharmacie

    Dijon 2013 - maintenant Master's degree, Operational & International Management in the Healthcare Industry

    • Regulatory Affairs (Development & International Registration, Supports as CTD & Pharmacopoeias)
    • Quality Assurance (Qualifications & Validations, CAPA, Audit, Quality Control, GMP)
    • Team Management
    • English (TOEIC 805)

  • Université De Bourgogne Faculté de Pharmacie

    Dijon 2008 - maintenant Pharm.D

    Biomedical, pharmaceutical and clinical sciences. Other courses include pharmacotherapeutics,
    pathophysiology, pharmacokinetics, physical assessment, clinical trials, immunopathology
    statistics, biotechnologies, pharmacy management

    • Teaching unit: Pathophysiology of Cardiovascular Diseases
    • Teaching unit: Management and Analysis of Environnemental Risks

  • Lycée Saint Francois De Sales

    Troyes 2005 - 2008 Baccalaureate with distinction

    Major in Sciences

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