Nicolas Colombo
European Regulatory Affairs Manager, Arysta LifeScience
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
32 contactsProvide 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
Ensure Annex I inclusion for 2 voluntarily withdrawn AIs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
NB: this role account for 60-70% of my time
2004 - 2008Responsibility 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.