Dr. Irene Gatti is a consultant with 15 years of experience leading global biotech traits regulatory teams, rooted in two decades of R&D working experience in the seed industry. Irene has strong knowledge of biotech traits regulatory and compliance requirements in different stages of R&D and proven ability to facilitate activities across geographies. She has an established track record of efficiently leading global regulatory projects that successfully reached commercialization in a timely manner.
Irene’s experiences include:
She successfully obtained United States Department of Agriculture (USDA), US Food and Drug Administration (FDA) and US Environmental Protection Agency (EPA) regulatory approvals for different crop biotech traits commercial launchings in the US. This success required developing proper strategic planning, effectively interfacing with regulatory agencies, coordinating all activities involved in the establishment of regulatory studies and the writing, reviewing and editing of regulatory submissions.
She had a key role in obtaining approvals for biotech traits commercial launchings in Argentina and Brazil. Her efforts included efficaciously designing and implementing regulatory plans and communicating with regulatory networks in those countries.
Working with local teams, she attained authorization for regulatory field trials and off season nurseries for genetically engineered plants in Costa Rica, Chile, Argentina, Brazil and Mexico.
She secured biotech traits import approvals, in conjunction with local partners in Australia, Canada, Brazil, EMEA, Japan, Korea and Mexico, to facilitate global crop trade. As part of this process, she established fluent relations with the regulatory networks in those countries.
Irene has significant experience with strategic regulatory project planning and assessment of regulatory requirements. Some of the specific skills include effectively complying with regulatory timelines, project costs, foreseeing and planning for potential issues and developing overall global regulatory status analyses.