Coordinador de Asuntos Regulatorios

Coordinador de Asuntos Regulatorios

Main Objective

Support regulatory strategy to obtain food and feed import authorizations for biotech products in LAN countries. It will be responsible for coordinating dossier writing, request for reference materials and submission of applications to obtain authorizations of GM products for human, animal consumption and industrial processing.

Main Responsibilities

·   Prepare dossier writing according to in-country regulatory requirements with COFEPRIS

·   Follow up with regulatory agencies until final authorization is obtained

·   Active coordination with STL product RAMs to access technical information for dossier preparation and request for reference materials.

·   Align with project management expectations to deliver timely authorizations according to global submission data base.

·   Interact with government regulators, AgroBio-CAR and biotech scientists as appropriate

·   Coordinate with RA and RP&SA teams to provide sound technical arguments in response to questions by Regulatory Agencies

Education and Experience Required

·   Bachelor Degree Biology, Biotechnology or Chemistry.

·   M.Sc. or PhD desired

·   At least 3 years of experience in Agricultural Research and Development

·   Experience in dossier writting and knowledge in COFEPRIS

·   Excellent written/oral communication skills

·   Englsh advanced (95%)

Contacto

Mandar correo a maria.fernanda.montenegro@monsanto.com