Regulatory Affairs Specialist

hace 2 semanas


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

Job Description:

Objetivo del cargo Regulatory Affairs Specialist Animal Health:

Respaldar al Director Científico en su actuación ante el Instituto Colombiano Agropecuario en Colombia, con el fin de asegurar el cumplimiento de las regulaciones regionales por parte de la operación de la compania en el país.

Colaborar en el proceso de registro para asegurar la aprobación y/o renovación de nuevos productos, permisos de manufactura, permisos de importación y mejoras de productos en Colombia.

Contactar con Gerente de Asuntos Regulatorios y con las diferentes unidades de negocio, Mercadeo, investigación y desarrollo, finanzas y otros departamentos relacionados, las necesidades de registro de componentes y sus tiempos.

Actuar como Back Up del Gerente de Asuntos Regulatorios y/o Director Científico (CORA) como referencia para el manejo de reportes de eventos adversos en la región, si es requerido por DPOC regional.

Relaciones con los organismos gubernamentales para las condiciones regulatorias requeridas.

Funciones/responsabilidades:


Asegurar la preparación, presentación y seguimiento de Dossier para obtener registro y/o renovación de los productos ante las autoridades del país.

Respaldo de CORA como QPPV para Colombia

Manejo de procesos internos de desarrollo y actualización de productos

Requerimientos del cargo:

Médico Veterinario

Experiência en asuntos regulatorios 2-3 años bien sea en el sector privado (industria) o del sector público (ICA)

Idiomas:
manejo del Inglés (60-80%)

Entrenamiento en sistemas:
Conocimiento básico de Office

Search Firm Representatives Please Read Carefully

Employee Status:

Project Temps (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R241115

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