Participate in current molecules development activity and provide Regulatory input
CMC discussion & trouble shooting with CFT’s for DMF compilatio
DMF review as per Health Authority & Customer requiremen
Submission of DMF in CTD & eCTD format
Perform DMF Gap analysis and Risk mitigatio
Customer qualification support and address the prerequisite
Customer support with AP DMF, DS/DP registration, QP audit reports & review cycl
Regulatory agency query - preparing the action plan in discussion with CFT and submitting the response to H
Review the change controls (CCF) and provide DMF impact assessmen
Post approval change assessment and customer notificatio
Customer migration support (LCM) & business continuit
Maintain submission tracker for DMF filings, Amendments, Annual report
Tracking Regulatory commitments and completenes
DMF SAP clearance for suppl
Support CFT’s - APQR, CAPA, OOT/OOS, Customer audit, etc.
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📌 Senior Manager (Bengaluru)
🏢 Biocon
📍 Bengaluru
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