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11/02 Ravindra Singh
HOD- Human Resource at Sone India Group of Industries

Views:138 Applications:3 Rec. Actions:Recruiter Actions:0

Sone India - Regulatory Affairs Role (2-10 yrs)

Punjab/Ludhiana Job Code: 30501

- 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.

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