Assistant General Manager - Regulatory Affairs - Pharma

- 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.