Nonclinical Submission Manager
hace 2 semanas
**Descripción**:
Como Nonclinical Submission Manager trabajarás con los científicos no clínicos de AstraZeneca y los colegas de regulación para gestionar la planificación, preparación y finalización de todas las contribuciones no clínicas, incluidos los conjuntos de datos SEND para las presentaciones regulatorias (principalmente FTIH y solicitudes de comercialización) durante todo el ciclo de vida del producto. Será responsable de la gestión de una cartera de proyectos con arreglo a los objetivos y normas de calidad acordados, por lo que deberá ser eficiente, orientado a los resultados y capaz de comunicarse eficazmente en equipos de proyecto, trabajando con plazos ajustados. Las habilidades organizativas y de liderazgo son esenciales, así como un alto control de calidad.
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**Requisitos**:
Licenciatura o equivalente en una disciplina científica relacionada con el desarrollo de fármacos o productos biológicos.
Experiência en la industria farmacéutica con conocimientos de los principios farmacológicos, toxicológicos y farmacocinéticos y su aplicación en la presentación de solicitudes reglamentarias.
Capacidad demostrada de gestión de proyectos
Persona motivada y emprendedora que se sienta cómoda trabajando en varios proyectos en paralelo.
Conocimiento de los requisitos normativos de la FDA y la EMEA, las directrices ICH y su aplicación.
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