Especialista de Asuntos Regulatorios (Bogotá)

Position location: Bogotá, Colombia – Established Pharmaceuticals division.

What You’ll Do

• Receive data from affiliates to consolidate reports for regional teams.
• Include updates for the global plan in the template based on information received by RA Leaders.
• Follow up with QA, clinical, and TPMs to request the different modules to ensure dossiers can be prepared by the RA Specialists.
• Follow up and maintain the RA database 2024 plan updated according to the approvals or submissions reported by the affiliates.
• Ensure change controls have activities uploaded in the system and that activity owners receive a reminder to close the change control.
• Notify deviations to their respective due dates.
• Follow up on indication updates in the risk assessment for labeling distribution.