Tiempo completo cmc jobs in Sevilla, España.

... required. 4+ years of experience in Analytical/ Cell & Gene Therapy Regulatory Affairs. Mandatory technical experience in ATMP / Gene therapy; Analytical; US and EU CMC regulatory Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality ...

... compañía. Se precisa incorporar a un/a auxiliar de laboratorio (operario/a de Planta Piloto) dentro del grupo de Process Development, Plasma Product Development, CMC de la División Scientific Innovation Office de Instituto Grifols SA, empresa especializada en la investigación, desarrollo, producción de proteínas plasmáticas ...

... reports; EU Type IA, IB and II variations), and an understanding of how requirements and timelines differ in other markets. - Personal authorship of regulatory CMC content: Module 3 sections, quality summaries, change justifications and contributions to health-authority responses. We will ask what you wrote, not only what ...

... required. 4+ years of experience in Analytical/ Cell & Gene Therapy Regulatory Affairs. Mandatory technical experience in ATMP / Gene therapy; Analytical; US and EU CMC regulatory Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality ...

... compañía. Se precisa incorporar a un/a auxiliar de laboratorio (operario/a de Planta Piloto) dentro del grupo de Process Development, Plasma Product Development, CMC de la División Scientific Innovation Office de Instituto Grifols SA, empresa especializada en la investigación, desarrollo, producción de proteínas plasmáticas ...

... Elaborar informes de desarrollo de productos, redactar y revisar el resumen general de calidad y otros documentos para respaldar las solicitudes reglamentarias de CMC con vistas a su presentación y para responder a las cartas de deficiencias. Preparar y aprobar la documentación científica para asuntos de calidad y reglamentarios ...