Jefe de Asuntos Regulatorios
Toluca, Mexico Permanent Date posted 25/06/2024- Ubicación: Ocoyoacac
Acerca del trabajo
Asegurar el cumplimiento regulatorio del sitio y los productos manufacturados en Ocoyoacac apoyándose del Sistema de Gestión de Calidad y las relaciones transversales con las áreas industriales y comerciales, gestionando trámites ante COFEPRIS
En Sanofi ConsumerHealthcare, construimos marcas de confianza y queridas que conectan con cientos de millones de consumidores en todo el mundo. Nuestra misión es permitir un mejor autocuidado para las personas y comunidades, a la vez que contribuimos a un planeta más saludable. Nos esforzamos por actuar como una fuerza para el bien, integrando la sostenibilidad en nuestro negocio y la misión de nuestros empleados, operando de manera responsable desde un punto de vista social y medioambiental. Para lograr esto, necesitamos personas que puedan moldear el futuro de nuestro negocio y ayudarnos en nuestro camino hacia llegar a ser la mejor empresa de autocuidado por y para el mundo.
Responsabilidades principales:
- Soportar al sitio realizando trámites legales/administrativos para los documentos que son responsabilidad de Asuntos Regulatorios Industriales
- Asegurar que los trámites regulatorios del sitio industrial sean sometidos en tiempo y forma a COFEPRIS y otras Autoridades Sanitarias internacionales, con el fin de dar apoyo al mantenimiento del cumplimiento regulatorio del sitio de manufactura,
- Realizar el sometimiento y seguimiento a los trámites de solicitudes y de visitas de verificación de Buenas Prácticas de Fabricación.
- Realizar la evaluación regulatoria de los controles de cambio, asegurando la difusión e implementación de cambios regulatorios locales
- Identificar, evaluar y controlar los impactos/ aspectos y riesgos de Higiene, Seguridad y Medio Ambiente
Acerca de ti
- Experiencia: En el área de asuntos regulatorios en la elaboración/manejo de Dossier técnico, registro, modificaciones, renovación en México y en el extranjero, trámites regulatorios y procesos de manufactura en la Industria Farmacéutica.
- Competencias sociales y habilidades técnicas: Sistema de Gestión de Calidad, Regulación sanitaria de medicamentos en cumplimiento de estándares nacionales y Orientación a resultados
- Formación: Químico o afín
- Idiomas: Ingles Avanzado
¿Por qué elegirnos?
- Dar vida a los milagros de la ciencia
- Descubrir infinitas oportunidades para hacer crecer su talento e impulsar su carrera, ya sea a través de un ascenso o un traslado internacional
- Disfrute de un paquete de recompensas bien diseñado que reconoce su contribución y amplifica su impacto.
PursueProgress. DiscoverExtraordinary
El progreso no se consigue sin personas, personas de diferentes entornos, en diferentes ubicaciones, desempeñando roles diferentes, todas unidas por una sola cosa: el deseo de hacer que los milagros se hagan realidad. Tú puedes ser una de esas personas. Busca el cambio, adopta nuevas ideas y explora todas las oportunidades que podemos ofrecer. Persigamos el progreso. Y descubramos juntos lo extraordinario.
En Sanofi, ofrecemos las mismas oportunidades a todo el mundo, independientemente de su raza, color, ascendencia, religión, sexo, país de origen, orientación sexual, edad, nacionalidad, estado civil, discapacidad o identidad de género.
Mira nuestro vídeo de A por todasy echa un vistazo a nuestras iniciativassobre la Diversidad, Equidad e Inclusión en Diversity, Equity, and Inclusion In and Beyond the Workplace (sanofi.com)
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