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Morgan DANVEL

Courbevoie

En résumé

4 years of experiences in Pharmacovigilance and International Regulatory Affairs.
International placement: 4 months in the Ministry of Health of Morocco (Pharmacovigilance), 18 months in the US (Regulatory Affairs)
Expectations: work an develop competencies in an international environment within Pharmaceutical/Biotech companies.

Entreprises

  • Galderma - Regulatory Affairs - Area Support Associate ASIA

    Courbevoie 2014 - maintenant

  • O4CP - Regulatory Affairs & Pharmacovigilance Project Manager

    2012 - 2014 • Regulatory strategy & IND, CTD US/EU submission
    • PIP, Scientific Advice, Orphan Drug Designation US/EU
    • Case assessment, DSUR & Brief Report submission
    • Quality Assurance support

  • SANOFI PASTEUR - Regulatory Affairs Planner - Swiftwater (US)

    Lyon 2010 - 2012 • RA Planner for 31 projects including C. difficile infection vaccine (flagship project)
    • Core Team member of the Regulatory Affairs Variation Lifecycle project
    • Resource management, budget process, Long Range Plan
    • Interfaces with project leaders & top management

  • Sanofi Pasteur - Regulatory Affairs - ASEAN + Korea Business Unit

    Lyon 2010 - 2010 • New registrations, Renewals and Life Cycle Management of sanofi pasteur’s portfolio
    • Contribution to preparation of answers to questions raised by Health Authorities
    • Tender applications
    • Operational Support to local affiliates
    • Regulatory intelligence
    • Interfaces with Marketing, Medical, Supply Chain departments, Commercial Operations, industrial and Quality affairs.

Formations

  • Université Montpellier 2 Sciences Et Technique Du Languedoc

    Montpellier 2009 - 2010 MASTER 2

    International Regulatory Affairs of Pharmaceutical Industries & Products - Master Degree “International regulatory affairs of Pharmaceutical industries & products"
    • Industrial environment & protection
    • European & International registration of pharmaceutical products
    • Marketing strategy & industrial enhancement

  • Faculte De Pharmacie De Caen

    Caen 2004 - 2009 Industrie pharmaceutique - Pharmaceutical studies with distinction
    Module “public & private law, environment & public health”

Réseau

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