Regulatory Affairs Coordinator
hace 3 semanas
PROPOSITO:
- Apoyo en coordinar y participar en la planeación, definición, implementación y seguimiento a los procesos regulatorios adecuados para garantizar la comercialización de los productos Pfizer a su cargo, incluyendo: Trámite de registro sanitario de los productos nuevos, renovaciones, modificaciones, entre otros, acorde con la reglamentación sanitaria y las políticas de la compañía y alineado con las necesidades corporativas y/o áreas del negocio.
- Brindar información veraz y oportuna sobre los productos a su cargo a la Gerencia de Asuntos Regulatorios para toma de decisiones.
- Apoyar las áreas de soporte/negocio de la compañía en temas regulatorios asociados a los productos a su cargo.
- El analista de Asuntos Regulatorios debe cumplir con las políticas, procedimientos operativos y lineamientos corporativos requeridos para cualquier empleados de la compañía, así como con los aplicables específicamente a su cargo. En ese sentido debe asegurar el 100% de cumplimiento en entrenamiento, el cual se audita mensualmente.
AREA DE RESPONSABILIDAD ARGENTINA
- Solicitar, recopilar, analizar, estudiar, preparar, presentar la documentación necesaria para la obtención de registros nuevos y modificaciones de registros sanitarios de los productos a su cargo, y hacer seguimiento ante la autoridad sanitaria dando repuesta a los requerimientos que se presenten. Incluye revisión técnica de dossiers y aseguramiento de preparación de documentación para sometimiento ante autoridades sanitarias, así como cumplimiento de cambios de labeling (CDS- Core Data Sheet) aplicable a los productos a su cargo.
- Revisar textos de material de empaque de productos farmacéuticos, cosméticos y suplementos dietarios nuevos o por modificación de textos, con el fin de contar con empaques acordes con la reglamentación sanitaria, para lograr que estén debidamente aprobados por la autoridad sanitaria, evitando atrasos, reprocesos, destrucciones o sanciones por falla de textos regulatorios en los empaques.
- Ser back up para revisar y aprobar los materiales promocionales de los productos a su cargo con el fin de contar con material promocional acorde con la reglamentación sanitaria.
- Dar soporte en las evaluaciones regulatorias de proyectos solicitados por Casa Matriz para el lanzamiento de nuevos productos.
- Participación en reuniones internas y/o externas nacionales e internacionales a las que sea designado por el Gerente de Asuntos Regulatorios (ej: Convenciones de ventas, Auditorias, Reuniones Cámara Farmacéutica, Reuniones con la autoridad sanitaria, Reunión de Proyectos, etc)
- Apoyar las áreas de soporte/negocio de la compañía en temas regulatorios asociados a los productos a su cargo.
- Dar soporte a la evaluación del impacto regulatorio en los controles de cambio locales e internacionales para los casos que aplique.
- Seguimiento y actualización de los registros sanitarios asociados a los productos a su cargo.
- Seguimiento y actualización de los sistemas regulatorios como PEARL, GDMS, RADARS.
FORMACIÓN ACADÉMICA
- Titulado en Química y Farmacia
HABILIDADES TÉCNICAS
- Conocimiento en de las regulaciones de medicamentos.
- Conocimiento básico en la regulación alimentos y cosméticos.
- Conocimiento básico del entorno regulatorio y las tendencias de la normativa que puedan afectar al negocio.
- Inglés
HABILIDADES GERENCIALES
- Muy buenas relaciones interpersonales y trabajo en equipo.
- Gran capacidad de trabajar bajo presión.
- Seguimiento
- Entender necesidades del negocio, ser estratégico
- Análisis, toma de decisiones y solución de problemas
- Orientación a la calidad y cumplimiento
- Planificación y organización
- Influencia, negociación
- Comunicación efectiva
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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