Senior Manager

Job description

Participate in new 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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