Regulatory Affairs Manager
hace 3 semanas
Regulatory Affairs Manager CDMX
En Fyte estamos en búsqueda de un Regulatory Affairs Manager para una empresa farmacéutica internacional
Buscamos conectar con
Profesionales con al menos 10 años de experiencia laboral en Asuntos Regulatorios para la industria farmacéutica.
¿Qué responsabilidades tendrás?
- Asegurar que todos los productos y procesos cumplan con las normativas locales e internacionales aplicables en México.
- Supervisar la obtención y mantenimiento de licencias y autorizaciones regulatorias, asegurando la conformidad con las regulaciones aplicables.
- Coordinar la preparación, revisión y presentación de la documentación regulatoria para nuevos productos, modificaciones, y renovaciones.
- Asegurar la organización y el mantenimiento de archivos regulatorios, garantizando la accesibilidad y precisión de la información.
- Actuar como el principal punto de contacto con las autoridades regulatorias en México, respondiendo a consultas y gestionando las solicitudes regulatorias de manera eficiente.
- Desarrollar y ejecutar estrategias regulatorias que faciliten la aprobación de productos y aseguren el cumplimiento continuo con las regulaciones.
- Anticipar riesgos regulatorios y proponer soluciones efectivas para mitigarlos.
- Mantenerse actualizado sobre cambios en las normativas y regulaciones, adaptando las estrategias y procedimientos internos en consecuencia.
- Participar en comités técnicos y brindar análisis de impacto sobre nuevas regulaciones y lineamientos.
- Proporcionar capacitación y apoyo en materia de regulación a otros departamentos, incluyendo desarrollo de productos, marketing, y ventas.
- Colaborar estrechamente con equipos internos y externos para asegurar la ejecución exitosa de estrategias regulatorias.
- Facilitar la comunicación efectiva y mantener informados a los stakeholders clave sobre los avances y cambios regulatorios.
Requisitos:
- Licenciatura en Ciencias Farmacéuticas, Ciencias de la Salud, o campos relacionados. Se valorará una Maestría en Asuntos Regulatorios o áreas afines.
- Sólido conocimiento de las regulaciones y directrices aplicables a productos farmacéuticos de prescripción y dispositivos médicos (por ejemplo, RIS, LGS, NOM-072, NOM-073, NOM-059, NOM-220, NOM-241, NOM-137).
- Mínimo de 10 años de experiencia en asuntos regulatorios, en la industria farmacéutica, biotecnológica o de dispositivos médicos.
- Sólidas habilidades organizativas, de comunicación y gestión de proyectos.
- Capacidad para trabajar de manera efectiva en un entorno híbrido y con equipos multidisciplinarios.
- Habilidad para anticipar y resolver problemas regulatorios complejos.
- Experiencia en la interacción con autoridades regulatorias y en la preparación de documentación para registros sanitarios.
- Conocimiento profundo del marco regulatorio mexicano para productos farmacéuticos y dispositivos médicos.
- Inglés avanzado (oral y escrito).
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