Regional Regulatory Manager

Role purpose
¿Interesado en saber más sobre este trabajo? Desplácese hacia abajo y descubra qué habilidades, experiencia y cualificaciones académicas se necesitan.
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:
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 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 budget ...