Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
- Co-ordinate with cross-functional teams and external stake-holders for query response discussion and distribute updated work plan
- *Create DMF master in LOA software & issue LOAs/CEPs
- Verify pre-approved documents
- Leverage product gap analysis #Preparation compilation and submission of the dossier documents I deficiency responses to agency as per the region specific requirements(for Para-IV -US) Preparation of MI documents, and collate the dossier/ deficiency responses package/DMF received from CDT and submit to the regulatory authority/customer
- Submit online audit dossier/DMF dong with queries