Role purpose
Es esencial asegurarse de que cumple con los requisitos como solicitante para este puesto;
por favor, lea atentamente la información a continuación.
Regulatory ownership of assigned active substances and/or formulated products to ensure delivery of the portfolio objectives in line with agreed business strategies and budget.
This role can be based within the EU
Job responsibilities
Obtain and maintain EU approval of active substances in line with agreed portfolio objectives through:
Perform and/or coordinate detailed Data Gap Analysis and Preliminary Risk Assessment, based on available information from the company or external parties
Effective coordination of work programmes with consultants and contract research organisation. Responsible for placing and monitoring the relevant studies in external laboratories. Accountable for dossier preparation including risk assessment in collaboration with consultants. Responsible for project bu...