Regulatory Affairs Analyst

hace 1 semana


Tlahuac, México Johnson & Johnson A tiempo completo

En **Johnson & Johnson **, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad.

La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la salud de más de mil millones de pacientes y consumidores todos los días durante más de 130 años. Independientemente de su raza, creencia, orientación sexual, religión o cualquier otro rasgo, TÚ eres bienvenido en todos los puestos vacantes en la compañía de cuidado de la salud más grande del mundo.

Cuando te unes a Johnson & Johnson, tu movimiento podría significar nuestro próximo avance.

Nuestra Misión nos impulsa.

Nuestros Pacientes nos inspiran.

Estamos buscando al mejor talento para la posición de **Regulatory Affairs Analyst** que estará localizada en **Ciudad de Mexico, Mexico.**

**Propósito**:Examinar, evaluar, investigar información relacionada con las actividades del departamento de asuntos regulatorios y ejecutar en tiempo y forma las actividades que le sean asignadas, así como el seguimiento y escalamiento oportuno. Colaboración con los especialistas de asuntos regulatorios en las actividades regulatorias requeridas para asegurar el registro de toda la información generada en el área además de asegurar el mantenimiento de los registros sanitarios. Cumplir con las regulaciones, lineamientos y códigos locales, políticas y procedimientos de la compañía.

**Principales Responsabilidades**:

- Ejecutar las siguientes actividades en tiempo y forma simultáneamente y considerando urgencias y necesidades del negocio:

- Organizar la solicitud, recolección, emisión, revisión, archivo y resguardo de la documentación técnico-legal del área, incluyendo archivos físicos y electrónicos. Elaboración y revisión de procedimientos, formatos e instructivos de trabajo.
- Implementar actividades que aseguren el mantenimiento y actualización en tiempo de los sistemas y bases de datos, cumplimiento de fechas planeadas, documentación y seguimiento de desviaciones, controles de cambio, entre otras. Elaborar reportes con el estado de cumplimiento de los procedimientos, actividades y métricas.
- Apoyar en las actividades del área relacionadas con: la preparación, revisión y sometimiento de trámites, tareas asignadas que requieran el uso de sistemas internos y corporativos, así como la preparación de paquetes de documentación para otras áreas.
- Mantenerse actualizado de los fundamentos/regulación para verificar que los productos de la compañía y actividades relacionadas se mantienen vigentes y en cumplimiento

**Qualifications**:
**Requisitios**:

- Licenciatura en Ciencias de la Salud; preferente en área farmacéutica, titulado o en curso.
- Inglés intermedio, oraly escrito.
- Experiência en Asuntos Regulatorios, documentación o calidada nível operacional deseable. Experiência en el registro de medicamentos y/o dispositivos, así comomantenimiento de los productos deseable.



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