Key Responsibilities :

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.

📌 AGM Regulatory Affairs (Canada Market) (Mumbai)
🏢 NMS Consultant
📍 Mumbai