Especialista de Asuntos Regulatorios

What You’ll Do

• Receive data by affiliates to consolidate reports to regional teams.
• Include updates for global plan in the template based on information received by RA Leaders
• Follow up to other areas QA, clinical and TPMs to request the different modules to ensure dossier can be prepared by the RA Specialists
• Follow up and keep 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 activities owners received a reminder to close the change control.
• Notify deviations to different due dates
• Follow up to indications updates in the risk assessment for labeling distribution.
• Follow up on inserts versions approved by manufacturing and receiving country
• Upload dossier for submission and validate its visualization in DARIUS
• Upload Dossier submitted to the different affil...