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AGM Regulatory Affairs

4 weeks ago

Mumbai, Maharashtra, India NMS Consultant Full time
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