Regulatory Affairs Specialist

hace 2 semanas


Bogotá, Bogotá D.E., Colombia ARIAD A tiempo completo

REGULATORY AFFAIRS SPECIALIST:

Bogotá, Bogota D.C.

Job ID R0117127

Category Research & Development

Subcategory Research & Development

Business Unit Global Portfolio Division

Job Type Full time

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 Heady 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 crossfuncionales.
  • 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 authorizationsand 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 theRegulatory Affairs Headand 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 nonpromotional 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 & Educatio

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