<p><strong>Regulatory Dossier</strong></p><ol><li>For new product, support for preparation of administrative document and submission in BPOM system and review dossier completeness based on checklist in accurately and timely manner</li><li>For maintenance, submit ready to submit dossier to BPOM system within 1 month after ready to submit dossier is dispatched or prepare document for submission that is not handled by COE team in accurately and timely manner</li><li>Prepare document related for submission and advertisement document &nbsp;(such as covering letter, statement letter , payment etc) for registration submission to BPOM or MOH</li></ol><p><strong>Regulatory submission</strong></p><ol><li>Register and process for verification of API and excipients for new product and existing product &nbsp;in BPOM registration system</li><li>For advertisement: Submit of all registration dossier, advertisement document for imported and local products to BPOM in timely manner including all additional data requested by BPOM</li><li>Submit registration dossier including any additional data requested by Indonesia HA through &nbsp;&nbsp;online BPOM registration&nbsp; system in accurately and timely manner</li></ol><p><strong>Regulatory database</strong></p><ol><li>Routine new aero monitoring (daily)</li><li>Input data (submission, approval and HA communication) into Corporate regulatory system in accurate and timely (within 5 wd)</li><li>Upload HA communication in Corporate regulatory system in accurate and timely (within 5 wd)</li></ol><p><strong>Other</strong></p><ol><li>Consult and respond appropriately with BPOM for verification and during submission&nbsp;</li><li>Process for payment of registration&nbsp; to finance department</li><li>Update information in MIMS quarterly</li><li>Do communication to Regional and COE for any deficiency letter or question from Indonesia HA for existing product and new product (if needed) in timely manner</li></ol>