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Nicolas COLOMBO

Saint Malo

En résumé

Broad knowledge of regulatory affairs
Strong problem solving ability and creativity in seeking solutions that take into account not only the science, but also the political environment in which regulatory decisions are made.
Project Management
Good team worker

Entreprises

  • Certis Europe - Head of Regulatory Affairs

    Saint Malo 2016 - maintenant

  • FMC - EAME Registration Manager

    2014 - 2015 Implementation and management of the registration strategy in the EU, Africa and Middle East
    Lead the European Registration Specialist team and ensure projects are moving along without delays (added focus on the progression and execution of FMC registration plans)
    Provide regulatory support to Management to facilitate business decisions and represent registration and product safety positions

  • FMC - Registration Manager

    2013 - 2014 Ensure Annex I Renewal for an active substance
    Analysis of technical needs for constitution of European and zonal dossiers
    Implementation, management and follow up of the registration strategy in the EU south zone, and Middle East
    Management (2,5 FTE)

  • Arysta LifeScience - Global Regulatory Affairs Manager for 2 AIs

    NOGUERES 2009 - 2011 Provide leadership to develop and maintain core dossier, define the global strategy and plans to manage critical issues.
    Drive more efficient and effective information sharing and project management
    Manage regulatory stream of global supply chain projects
    Understand the needs of the Business Units and provide support, as appropriate

    NB: this role account for 30-40% of my time

  • Arysta LifeScience - European Regulatory Affairs Manager

    NOGUERES 2008 - 2012 Ensure Annex I inclusion for 2 voluntarily withdrawn AIs
    Analysis of technical needs for constitution of European and national dossiers
    Submission, management and follow-up of National registration
    Estimation of project cost and budget follow-up
    Provide leadership on regulatory strategy for the 2AIs, working closely with Product Manager

  • Hygeia Chemicals Ltd, Ireland - Regulatory Affairs Officer

    2004 - 2008 Responsibility for maintaining and developing the Irish portfolio: management and follow-up of registration submissions to ensure product approvals were obtained in a timely manner.
    Constitution and submission of national dossiers
    Checking, updating and validation of label under Irish, UK and/or EU requirements.

Formations

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