30 Aug
|
Biocon
|
Bengaluru
Job description Participate in recent 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. ,
📌 Senior Manager (Bengaluru)
🏢 Biocon
📍 Bengaluru