Participate in recent molecules development activity and provide Regulatory inputCMC discussion & trouble shooting with CFT’s for DMF compilatioDMF review as per Health Authority & Customer requiremenSubmission of DMF in CTD & eCTD formatPerform DMF Gap analysis and Risk mitigatioCustomer qualification support and address the prerequisiteCustomer support with AP DMF, DS/DP registration, QP audit reports & review cyclRegulatory agency query - preparing the action plan in discussion with CFT and submitting the response to HReview the change controls (CCF) and provide DMF impact assessmenPost approval change assessment and customer notificatioCustomer migration support (LCM) & business continuitMaintain submission tracker for DMF filings, Amendments, Annual reportTracking Regulatory commitments and completenesDMF SAP clearance for supplSupport CFT’s - APQR, CAPA, OOT/OOS, Customer audit, etc.
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📌 Senior Manager (Mumbai)
🏢 Biocon
📍 Mumbai
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