HOD- Human Resource at Sone India Group of Industries
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Sone India - Regulatory Affairs Role (2-10 yrs)
- 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.