Regulatory Affairs Manager
hace 8 meses
**PROPÓSITO DEL ROL**
El gerente de Asuntos Regulatorios será responsable de liderar y ejecutar la estrategia regulatoria de Takeda en Argentina, siendo su principal foco:
- Implementación de todas las actividades relacionadas con la regulación siguiendo el plan estratégico del negocio para obtener oportunamente los registros, las autorizaciones de comercialización de nuevos productos, y garantizar el mantenimiento del portafolio aprobado (renovaciones, variaciones, etc).
- Cumplimiento de las presentaciones regulatorias a las agencias gubernamentales para productos existentes y nuevos.
- Mantenimiento de las habilitaciones ante los entes regulatorios (ANMAT / Ministerio de Provincia de Buenos Aires) y soporte regulatorio durante inspecciones relacionadas.
- Participación activa en proyectos multidisciplinarios, así como en reuniones de lanzamientos, reuniones con agencias gubernamentales y asociaciones de la industria.
- Supervisión del cumplimiento de las políticas locales y globales relacionadas con los procesos regulatorios.
Este rol reportará al Head de Asuntos regulatorios de Cono Sur.
**RESPONSABILIDADES**
- ** Liderazgo del equipo de RA**: Liderar al equipo de RA, garantizando planes de desarrollo sólidos para el talento del equipo.
- ** Estrategia regulatoria**: Desarrollar y ejecutar planes estratégicos de registro para productos innovadores y en línea con los planes comerciales para garantizar la disponibilidad del registro y autorización de comercialización en tiempo y forma.
- ** Colaboración crossfuncional**: trabajar en estrecha colaboración con equipos de las diversas áreas, incluidos Comercial, Comercialización, Asuntos Médicos, Servicios al Paciente, Acceso y Asuntos Corporativos locales, regionales y globales en todas las preguntas sobre normativa, para alinearse con las estrategias comerciales y de acceso.
- ** Pipeline**: trabajar con equipos médicos, de acceso y Bussiness Operations para asegurar la disponibilidad de los productos innovadores.
- ** Compliance**: Garantizar que todas las actividades cumplan con los estándares regulatorios y de Compliance.
- ** Engagement externo**: participar activamente en los equipos de trabajo de las asociaciones como CAEME y con las autoridades regulatorias con el fin de influir positivamente en las discusiones de nuevas normativas, proyectos de trabajo, trainings, etc.
**SKILLS**
**Experiência y Educación**:
- Farmacéutico, bioquímico, biotecnólogo o carreras afines.
- Sólidos conocimientos de la normativa local de productos sintéticos, biológicos, vacunas y productos médicos.
- Experiência trabajando en asociaciones / cámaras farmacéuticas y en interacciones con entes regulatorios (ANMAT/INAME/Ministerio de Salud de Provincia de Buenos Aires).
**Competencias y Habilidades**:
- Habilidades de liderazgo.
- Excelentes relaciones interpersonales.
- Alto poder de influencia y negociación con stakeholders internos y externos.
- Pensamiento crítico y habilidades para la resolución de conflictos.
- Idioma inglés intermedio/avanzado.
**Locations**:
ARG - Av Libertador 7208, piso 14
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
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