Regulatory Affairs Project Leader

hace 3 meses


Capital Federal Buenos Aires, Argentina Raffo A tiempo completo

Capital Federal, Capital Federal, Argentina

Salud, Medicina y Farmacia/Farmacéutica

Full-time
Presencial
Descripción del puesto

Nos encontramos en la búsqueda de un Regulatory Affairs Project Leader para Nuevas Licencias para el área de Asuntos Regulatorios (prod. de licencias)

Los principales desafíos serán
- Sólida experiência realizada principalmente en áreas regulatorias.
- Experiência en registro de productos biológicos/biotecnológicos.
- Manejo del marco regulatorio regional (Región LATAM siendo los principales mercados Brasil, México, Colombia, Argentina, Centro América, Chile, Perú, Ecuador, entre otros)
- Manejo de dossier de registro formato CTD
- Nociones del marco regulatorio internacional (ICH, CA, US, EU).
- Conocimientos generales de normas GMP, sistemas de calidad, operatorias de plantas farmacéuticas.
- Puede provenir de laboratorios locales o internacionales
- Obtención de registros sanitarios en tiempo y forma de acuerdo al plan y requerimientos del negocio.
- Cumplimiento con actividades regulatorias, en línea con el plan de negocio de la compañía y licenciante, requeridas o solicitadas por la autoridad o derivadas de la necesidad del negocio.
- Asegurar que los registros están alineados a los requisitos regulatorios vigentes (compliance).
- Asegurar mediante el seguimiento adecuado el cumplimiento de las obligaciones contractuales en cuanto a calendario, comunicación de la información de las Agencias regulatorias, respuesta de DL (deficiency letters), plazos, deadlines, etc.
- Mantenerse actualizado en cuanto a los cambios de requisitos regulatorios de la región.
- Preparar dossiers para trámites regulatorios: nuevos registros, renovaciones y modificaciones Post-Registro para small moelcules y productos biologicos/biotencloógicos para países de Latinoamérica. Evaluación general de la información del dossier de registro versus los requisitos.
- Envío y seguimiento de tramites regulatorios en países,
- Análisis de requerimientos ministeriales. Coordinación/preparación de respuestas técnicas, médicas y legales.
- Análisis de requisitos de países. Seguimiento de actualización de las regulaciones.
- Proveer información del avance de los trámites regulatorios en los países.
- Carga de información en sistema informático regulatorio / Planillas para reportes de gestión.
- Interacción cotidiana con clientes externos en idioma inglés y con clientes internos en idioma español.
- Mantener informado al Gerente respecto de los KPIs del sector, mapeo de riesgos y potenciales problemas de los proyectos a cargo.
- Funcionar como Experto Regulatorio (Back up del jefe) en los paneles técnicos de evaluación de potencial impacto regulatorio frente a los siguientes escenarios: controles de cambio, desvíos, evaluación de proyectos, etc.
- Coordinación de equipos inter-áreas sin reporte formal a la posición; e implementación de herramientas en linea con Regulatory Services

**Requisitos**:
Experiência laboral de Más de 5 años de experiência en la industria farmacéutica en áreas regulatorias, incluyendo 2 años en posiciones similares con manejo de proyectos regionales para obtención de registros de nuevos productos, y mantenimiento regional de registros vigentes. Región LATAM.

Orientamos la búsqueda a Universitarios Farmacéutico, Bioquímico, Biotecnología.

**Idioma**:
Ingles Avanzado (Excluyente)

La zona de trabajo es Saavedra y el horario de 08:00hs a 17:00 hs

Beneficios

**Se ofrecen excelentes condiciones de contratación**:
Horario de trabajo de lunes a viernes de 8:00 a 17:00 hs en Saavedra (CABA).
Prepaga Luis Pasteur - OSDE
Comedor en planta
Llave de snacks
21 días de vacaciones
Descuentos en Gimnasio, Educación y Consumo Masivo
Semana de las fiestas

Detalles

**Nível mínimo de educación**: Universitario (Graduado)
Nosotros

En Laboratorios Raffo contamos con un equipo de más de 1.500 personas, entre ellos se destacan profesionales de distintas especialidades los cuales trabajan todos los días para lograr la excelencia y la mejora continua.
Trabajamos para construir equipos motivados, talentosos y responsables. Estamos comprometidos con la atracción, motivación y retención de los mejores profesionales del mercado, brindando actividades de formación para todos los níveles de la organización.

Buscamos estimular el crecimiento integral de las personas fortaleciendo a todos los equipos de trabajo de la compañía. Además, propiciamos la generación y mantenimiento de un ambiente laboral cálido, productivo y de respeto mutuo que asegure un excelente clima de trabajo. Sumate a nuestro equipo



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