Handling ROW Latam market

1. Preparation & compilation of dossier for Asian Countries Cambodia and Vietnam. 2. Preparation of ACTD dossiers. 3. Preparation & compilation of CTD dossier. 4. Preparation & compilation of dossier for Latin American Countries & timely solve the queries. 5. Coordination with factory. 6. Coordination with Packaging development department for artwork initiation. 7. Preparation of Text Matter for artwork initiation. 8. Ensure accuracy, completeness and quality of regulatory submissions.

1. To overall coordinate the activities of CPU at ARL 2. To inform to the volunteer coordinators about the details of the study and confirm the participation of the required number of volunteers as per the study protocol. 3. Preparation of Trial Master File, source document, labels of the study. 4. To monitor the activity like dosing, collection and sample processing during study activity. 5. To review temperature of collection area, synchronization of clock and maintain the record of the same in log book. 6. To coordinate with pathology department and canteen department and to tell about study condition i.e. fast or fed. 7. To maintain volunteer data bank, Age certificate record. 8. To do all IP related activities like acceptance, dispensing, reconciliation etc.