AGM Regulatory Affairs

AGM position -Regulatory Affairs B.Pharm / M.Pharm / M.Sc– 12-14 years regulatory affairs experience majorly in USA market for Solid oral dosage forms Key Responsibilities: Ensure timely submission of ANDA’s, supplements and amendments Review of registration dossiers, amendments, supplements and annual reports prepared by subordinates for adequacy and correctness Life cycle management of product including maintenance, updation of changes to approved ANDAs Technical support at drug product development stage Keep abreast of latest regulations, interpreting and understanding guidance and disseminating the information to all concerned Key activities : Review of registration applications, amendments, supplements and annual reports for onward submission to USFDA. Training of subordinates on regulatory requirements Discuss and coordinate with technical dept. to ensure regulatory compliance throughout the life-cycle of product from formulation development and manufacturing of product to marketing authorization and post-approval changes Regulatory support to manufacturing sites during audits Life-cycle management of approved ANDAs Review and Approval of Change Control Proposals Monitoring and tracking of Regulatory database Support to marketing for commercial and launch activities Gap assessment of approved ANDAs wrt compliance to current requirements prior to product launch Evaluation and assessment of impact of post approval changes, regulatory strategy determination for supplement filing category

Created: 2025-08-05