REGULATORY AFFAIRS & LOCAL SAFETY TRAINEE job opportunity at Roche.

Home Jobs In Chile Tag: Job REGULATORY AFFAIRS & LOCAL SAFETY TRAINEE position at Roche


DateMore Than 30 Days Ago bot
Roche REGULATORY AFFAIRS & LOCAL SAFETY TRAINEE
Experience: General
Pattern: full-time
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loacation RM- Region Metropolitana de Santiago, Chile
loacation RM- Region Met..........Chile

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position La Oportunidad Aseguras el cumplimiento de todas las normativas de Asuntos Regulatorios según reglamentaciones locales, corporativas y de Dirección Técnica. Gestionas trámites ante el ISP, incluyendo registros de productos nuevos, renovaciones y modificaciones de registros vigentes. Actúas como apoyo del Local Safety Officer (LSO) para la afiliada, coordinando procesos de seguridad y comunicación a clientes. Monitoreas las métricas de vigilancia sanitaria y calidad de post-marketing para asegurar la conformidad de los productos en la cadena de suministro. Mantienes actualizadas las bases de datos locales y globales (RIM) de acuerdo a las nuevas actividades regulatorias de los productos. Procesas cambios de textos en empaques con los sitios de manufactura y creas artes para productos nuevos según la regulación local. Colaboras en la implementación del Sistema de Gestión de Calidad (ISO 9001, 13485) identificando brechas y realizando planes de acción. Proporcionas entrenamiento en manejo de reclamos y Tecnovigilancia a los empleados para cumplir con los estándares divisionales. Quién eres Cuentas con con título profesional en Química Farmacia, Tecnología Médica, Biología o Química. Cuentas con un nivel de inglés intermedio que te permite comunicarte efectivamente en un entorno global. Te destacas por tu alta competencia social y capacidad para comunicarte de manera precisa tanto en español como en inglés. Eres una persona motivada con un estilo de trabajo independiente pero altamente colaborativo. Demuestras compromiso con la excelencia, estableciendo prioridades y simplificando el trabajo diario. Requisitos Deseables Experiencia previa o conocimientos en Asuntos Regulatorios y/o Tecnovigilancia. Certificación o formación como auditor de sistemas de gestión de calidad (ISO 9001 u otro). Capacidad para definir metas estratégicas y alcanzarlas con un alto nivel de iniciativa. *Los beneficios de reubicación no están disponibles para esta vacante.     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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