Especialista de Asuntos Regulatorios

Location

Bogotá, Colombia

Responsibilities

• Receive data from affiliates and consolidate reports for regional teams.
• Include updates for the global plan in the template based on information received from RA leaders.
• Follow up with QA, clinical, and TPM areas to request modules ensuring dossiers can be prepared by RA specialists.
• Keep the RA database 2024 plan updated according to approvals or submissions reported by affiliates.
• Ensure change controls activities are uploaded in the system and reminder notifications sent to owners to close the change control.
• Notify deviations to their respective due dates.
• Track indication updates in the risk assessment for labeling distribution.
• Verify inserts versions approved by manufacturing and receiving countries.
• Upload dossiers for submission and validate their visualization in DARIUS.
• Ensure correct filling of information in DARIU...