Participate in current 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