Senior Manager

Job description

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. ,