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About this Practicante de Estudios Clínicos, Calidad, Farmacovigilancia y Asuntos Regulatorios 2027-1 role at Roche

Roche · Onsite · Bogota
This job posting is in Spanish.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Objetivo del Puesto:

Brindar apoyo a equipos de Asuntos Regulatorios, Calidad, Farmacovigilancia, Estudios Clínicos; en actividades relacionadas con la gestión de sometimientos regulatorios, sistema de gestión de calidad y farmacovigilancia/tecnovigilancia lo que le permitirá familiarizarse con las funciones de estas áreas de la industria farmacéutica y diagnóstica . Además, proporcionará soporte a las áreas correspondientes, apoyando el cumplimiento de las normativas nacionales e internacionales.

Responsabilidades:

  • Colaborar en la preparación y revisión de expedientes regulatorios para la presentación ante autoridades sanitarias.

  • Apoyar en la actualización y mantenimiento de bases de datos regulatorias.

  • Asistir en la recopilación y organización de documentación técnica y científica necesaria para las presentaciones regulatorias.

  • Realizar seguimiento de los procesos y plazos regulatorios, asegurando el cumplimiento de los mismos.

  • Participar en la elaboración de informes y reportes requeridos por las autoridades regulatorias.

  • Contribuir en la revisión y traducción de documentos regulatorios y científicos.

  • Mantenerse actualizado sobre cambios en la normativa regulatoria y comunicar dicha información al equipo.

  • Apoyar la documentación y evaluación de situaciones de seguridad, preparación de información de seguridad, reconciliación de casos y soporte a diferentes programas que conectar con la red. 

  • Colaborar en la preparación y revisión de expedientes regulatorios para la presentación ante autoridades sanitarias.

Requisitos:

  • Estudiante activo de las carreras de: Química Farmacéutica,  Enfermería, Ciencias de la Salud (médico, bacteriólogo, enfermería o carreras a fines) e Ingeniería Biomédica

  • Inglés intermedio

  • Disponibilidad de laborar jornada continua.

 

 

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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About Roche

We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

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