Opportunity Description
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...
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