Regional Regulatory Manager

Role purposeRegulatory 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:1. 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 partiesEffective 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 budget building and tracking.Effective management of relations and communication with (Rapporteur) Member States, DG SANTE, EFSA, HSE and internal EU Regulatory teamEffective partnership with...