Regulatory Affairs Specialist

hace 7 meses

Ciudad de México Johnson & Johnson SA de CV A tiempo completo

**Regulatory Affairs Specialist**
**-**
**2306138354W**

**Descripción**

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.

Segmento Farmacéutico - Janssen

Las compañías farmacéuticas de Johnson & Johnson se dedican a tratar de resolver las necesidades médicas que no han sido cubiertas y que son importantes actualmente, como la Oncología ( mieloma multiple y cáncer de próstata), inmunología ( artritis reumatoide, enfermedad del intestino irritable y psoriasis), neurociencia (esquizofrenia, demencia), enfermedades infecciosas (HIV/SIDA, la hepatitis C y tuberculosis) y enfermedades cardiovasculares y metabólicas (diabetes).
Impulsado por nuestro compromiso con los pacientes, desarrollamos soluciones de sanidad integradas con el trabajo de los actores de salud, basado en asociaciones de confianza y transparencia.

Resumen General

Asegurar la planeación, ejecución y seguimiento en tiempo y forma las actividades regulatorias relacionadas con el Life-Cycle Management de los productos de la compañía. Responsable del contenido, evaluación, comunicación de los proyectos y trámites de variaciones, cumplimiento de la regulación, captura, registro y archivo de la información en las bases de datos, repositorios y sistemas de la compañía.

Áreas de Responsabilidad

1. Promover el modelo de RMC con los equipos regulatorios locales. Ser el principal punto de contacto de RA LOC, y promover la comunicación con la región y áreas relevantes.
2. Evaluar y planear en conjunto con la LOC las variaciones de los productos, ejecutar en tiempo y forma las estrategias que soporten la continuidad y crecimiento del negocio, escalar las solicitudes locales o por parte de la autoridad.
3. Asegurar que los productos de la compañía y actividades relacionadas se mantienen vigentes, en condiciones adecuadas para la compañía.
4. Trabajar con los clientes internos para procesos específicos como actualización de sistemas, traducciones y gestión de artes. Actualización de sistemas relacionados con variaciones (Trackwise / Insight)
5. Manejar efectivamente diferentes proyectos de manera simultánea y cumplir con las fechas de sometimiento conforme a las necesidades del negocio.
6. Cumplir con las regulaciones, lineamientos y códigos locales y políticas de la compañía.

Colabora con:

- Internamente:
- Sitio de Manufactura México (Puebla)
- Oficina Regional Janssen Asuntos Regulatorios
- LoC
- RMC
- Oficinas globales de Labelling, CMC y RSMO.
- Externamente:
- Prestadores de servicio (Ej. Traductores, Terceros Autorizados)

**Calificaciones**

Preparación Académica: Mínimo: Licenciatura en Ciencias de la Salud; preferente en área farmacéutica, química o afín (ej. QFB; QFI) titulado
Idiomas: español avanzado e Inglés al menos intermedio, oral y escrito
Experiência Laboral:Al menos 1 ó 2 años de experiência en Asuntos Regulatorios a nível País.
Experiência de trabajo con equipos virtuales, y/o los equipos globales. Fuerte en la recopilación de datos, y la interpretación,
Manejo de sistemas de seguimiento de RA (TrackWise / Insight) - preferido.
Lugar de desempeño: Ciudad de México

**Ubicación principal** America Latina-México-Distrito Federal-Ciudad de México**Organización** Janssen Cilag de Mexico SA de RL de CV (Comercializadora) (7240)**Área** Regulatory Affairs

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