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