- Strategic planning for formulation development of DCGI batches in Plant to ensure timely submission in CDSCO

- Planning, compilation, review and submission of dossiers related to Import and Registration, New Drug permission, test license etc. to CDSCO.

- Uploading the documents on SUGAM portal and on the portals of other State Regulatory Authorities.

- Handling and responding to all the product specific queries.

- Ensuring overall compliance to domestic regulatory requirements.

- Co-ordination with respective departments.

- Maintaining familiarity with company product ranges.

- Keeping up to date with changes in regulatory legislation and guidelines.

- Ensuring that quality standards are met and submissions meet strict deadlines.

- Maintain high levels of accuracy, meet tight deadlines.

- Management of Data.

- Handling work related to planning and timely procurement of Innovator sample.

- Handling work related to CROs i.e. planning, selection, completion of BE, CT, Toxicity studies.

- Preparing DRA's MIS presentation (Quarterly basis) to management.

- Preparation and submission of DRA's Performance review plan (PRP) (Quarterly basis) to Management.

- Maintaining Product Registration Certificates received.

- Timely answering Queries raised by Health Authorities of respective countries and customers.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.