Job description

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