Regulatory Affairs Specialist

hace 2 semanas


Bogota, Colombia Takeda Pharmaceutical A tiempo completo

**Regulatory Affairs Specialist**

**_ Versión Español_**

**PROPOSITO DEL ROL**

Este rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de comercialización y variaciones, tanto para productos existentes como nuevos. Además, coordinará las actividades de Excelencia Regulatoria en Colombia asegurando el cumplimiento de los requisitos regulatorios globales de la compañía y las regulaciones locales del país en coordinación con todas las áreas interesadas.

Este puesto reporta al Regulatory Affairs Head y tiene su sede en Bogotá, Colombia.

**DESAFIOS EN LA POSICIÓN**
- Apoyar la presentación de expedientes para evaluación farmacológica, expedientes técnicos y legales para la aprobación de Registros Sanitarios, así como modificaciones de Registros Sanitarios para productos en comercialización y para nuevos productos.
- Preparar respuestas regulatorias para resolver las preguntas de la Autoridad Sanitaria a tiempo.
- Liderar el proceso de aprobación y mantenimiento de las autorizaciones de urgencias clínicas (NPP).
- Mantener el seguimiento con la Autoridad Sanitaria local para obtener las aprobaciones de acuerdo con la planificación de asuntos regulatorios.
- Revisar y aprobar la Información para Prescribir e insertos locales.
- Soporte (si es necesario) para la creación de LCRs y solicitudes RFM.
- Evaluar los cambios de CCDS y realizar los sometimientos a nível local de acuerdo con los plazos corporativos.
- Cumplir a tiempo con los sometimientos regulatorios y definir estrategias para cumplir con las fechas de aprobación esperadas.
- Revisión y aprobación de artes de etiquetado de los productos.
- Revisión y aprobación de materiales promocionales y no promocionales.
- Asistir a reuniones con la Autoridad Sanitaria.
- Identificar, alinear e implementar estrategias de mitigación de riesgos para todos los procesos regulatorios.
- Ejecutar la estrategia de inteligencia regulatoria para Colombia mediante el monitoreo del estado regulatorio de los competidores y el monitoreo, evaluación del impacto y aplicación de las nuevas regulaciones.

**A QUIEN BUSCAMOS**

**Experiência y educación**
- Conocimiento de la regulación en Colombia.
- Dominio mínimo del inglés al 80%.
- Mínimo 3 años de experiência en Asuntos Regulatorios, enfoque en productos biológicos, biotecnológicos, además de productos de síntesis química.
- Sólido conocimiento del entorno regulatorio de Colombia y de las operaciones de la Autoridad Sanitaria.
- Orientación a resultados y enfoque en ejecución oportuna.

**Competencias y habilidades**
- Pensamiento estratégico.
- Orientación a resultados.
- Comunicación asertiva, habilidad para crear conexiones con los equipos cross-funcionales.
- Experiência laboral en equipo multidisciplinario.
- Pensamiento crítico y resolución de problemas.
- Trabajo en equipo y comunicación
- Centrados en el cliente.
- Habilidades de gestión para resolver problemas.

**UBICACIÓN**:Bogota, Colombia.

****
- English version_

**WHAT YOU WILL DO**

The position is accountable of support the business strategic plan to obtain marketing authorizations and variations, both for existing and new products and coordinate Regulatory Excel-lence activities in Colombia ensuring compliance to company Global Regulatory requirements (pro-cesses & tools) and to local Country Regulations in liaison with all the concerned areas.

This position reports to the Regulatory Affairs Head and is based in Bogotá, Colombia.

**WHAT YOU WILL WORK ON**
- Support the submission of pharmacological, technical, and legal dossiers for Marketing Authorizations, as well as Marketing Authorizations variations for products in the portfolio and for new products.
- Provide support to prepare regulatory responses to resolve agency questions on time.
- Lead the process to obtain approval and maintain clinical urgencies submissions (NPPs).
- Maintain follow up with the local HA to obtain the approvals according with the RA planning.
- Review and approve local labelling material.
- Support (if required) creation of LCRs and RFM requests.
- Evaluate CCDS changes and submit at local level according with corporate timelines.
- Keep on track regulatory submissions and define strategies to comply with expected approval dates.
- Artworks review and approval.
- Promotional and non-promotional materials review and approval.
- Attend meetings with HA.
- Identify, align and implement risk mitigation strategies for all regulatory processes.
- Perform regulatory intelligence strategy for Colombia by monitoring of regulatory status for competitors and monitoring, assessing impact and scaling up of new regulations.

**WHO ARE WE LOOKING FOR**

**Experience & Education**
- Knowledge of regulation in Colombia.
- Minimum proficiency in English 80%
- Minimum 3 years of experience in Regulatory Affairs, focus on biological, biotechnological and small molecules.
- Solid knowledge of Colom



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