Regulatory Affairs Specialist
hace 2 días
Ferrer Internacional Sa busca un/a Regulatory Affairs Trainee para unirse a nuestro equipo de profesionales comprometidos con la innovación y el desarrollo de productos farmacéuticos de alta calidad.
Funciones clave:- Gestionar la preparación, presentación y mantenimiento de las autorizaciones de comercialización de los medicamentos y resto de productos de la compañía.
- Generar y recopilar toda la información interna y externa para la evaluación o mantenimiento de los dossiers.
- Seguimiento de los dossiers presentados a registro ante las autoridades correspondientes en cada país siguiendo la estrategia regulatoria de la compañía.
- Mantenimiento y actualización de los dossiers de registro (variaciones y revalidaciones quinquenales).
- Dar soporte en las ofertas y auditorías de posibles licenciadores y licenciatarios, desde el punto de vista técnico (calidad del dossier, plazos, procedimientos, etc.).
- Mantener un conocimiento actualizado de la normativa publicada y de aplicación en el ámbito de registros de todas las categorías de productos, así como prestar soporte a los diferentes departamentos implicados.
- Mantener las bases de datos del departamento.
- Formación académica: Licenciatura en ciencias de la salud (Química, Farmacia, Bioquímica, Biología).
- Idiomas: Español e Inglés nivel avanzado hablado y escrito.
- Informática: A nivel de usuario.
- Necesarias buenas capacidades de relación, comunicación, aprendizaje, adaptación, flexibilidad y espíritu crítico.
- Horario: De lunes a jueves jornada completa 9-18h. Viernes jornada intensiva de 9-14h.
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Barcelona, Barcelona, España Galderma Pharma S.A A tiempo completo{"title": "Regulatory Affairs Specialist", "description": "Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Galderma Pharma S.A. in Barcelona. As a key member of our Regulatory Affairs department, you will be responsible for preparing and updating CMC dossier sections for assigned products, contributing to global...
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