Regulatory Affairs Specialist

hace 3 semanas


Bogota, 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



  • 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...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. - Leads or compiles all materials required in submissions, license...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER27699 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible for assisting the team with regulatory change assessments and filings as necessary to market and maintain Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as a understanding...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    **Regulatory affairs specialist**: At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER28216 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...


  • Bogota, Colombia SGF Global A tiempo completo

    **Role description** - Coordinate the Regulatory Affairs activities at the export markets (Ecuador, Peru, Venezuela, Bolivia, Paraguay and Uruguay) - Implement and execute Regulatory Affairs processes and policies ensuring that all the aspects of the product safety are closely monitored and fulfil the regulatory requirements through ongoing support and...


  • Bogota, Colombia MSD A tiempo completo

    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 MSD AH en el país. Colaborar en el proceso de registro para asegurar la aprobación y/o...


  • Bogota, Colombia SGF Global A tiempo completo

    **Role description** - Coordinate the Regulatory Affairs activities at the export markets (Ecuador, Peru, Venezuela, Bolivia, Paraguay and Uruguay) - Implement and execute Regulatory Affairs processes and policies ensuring that all the aspects of the product safety are closely monitored and fulfil the regulatory requirements through ongoing support and...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson Vision, a member of Johnson and Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist located preferably in Colombia, or Mexico. An exciting opportunity to join a diverse team. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


  • Bogota, Colombia MSD A tiempo completo

    This role will strategically execute the regulatory road map for our portfolio and pipeline to support company success and growth, by creating the greatest value for patients and in turn all stakeholders. Ensure compliance with local legislations to achieve the regulatory objectives, provide advisory and support to key stakeholders such as marketing,...


  • Bogota, Colombia Takeda Pharmaceutical A tiempo completo

    **Regulatory Affairs Lead** **WHAT YOU WILL DO** The role exists to lead and coordinate Regulatory Excellence activities in Colombia, ensuring compliance to company Global Regulatory requirements (processes & tools) and to local Country Regulations in liaison with all the concerned areas. Responsible for acting in compliance with country policies and...


  • Bogota, Colombia Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Intern Regulatory Affairs

    hace 3 semanas


    Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER29097 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities...

  • Intern Regulatory Affairs

    hace 3 semanas


    Bogota, Colombia Zimmer Biomet A tiempo completo

    -Requisition Number AMER29097 Employment Type Full-time Location Bogota **Job Summary**: - The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities related to the...


  • Bogota, Colombia Unilever A tiempo completo

    Regulatory Affairs Manager - Colombia Diversity is one of our most relevant pillars and our main objective is to develop an internal environment open to the multiplicity of thoughts, through inclusion without stereotypes. This allows us to value the best professionals, bringing together diverse profiles and styles, and better facing the current and future...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


  • Bogota, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...


  • Bogota, Colombia Johnson & Johnson Family of Companies A tiempo completo

    Regulatory Affairs Manager - LA North Cluster At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion...