Designation: Head/GM - DRA

Experience: 15+, 5 yrs exp into liasioning 

Location: New Delhi

Resposibilities:

1. Liaison and Coordination at CDSCO for approval of various applications related to IND, New Drugs, Subsequent New Drugs, Fixed Dose Combinations, BE for Export, Import, Medical Device and Biologicals. Inclusion of various proposals in different expert committee meetings.

2. Liaison and Coordination with Department of Biotechnology for the approval of various applications related to Bio-Similars.

3. Liaison and Coordination with the Directorate of Science and Industrial Research for approval & Recognition of In House R&D Centers and certification of their expenses

4. Liaison and Coordination with Central & Regional FSSAI for various applications related to product approvals and licenses.

5. Liaison and Coordination with the Officials of Ministry of Health & Family Welfare regarding matters related to Government Policies

6. Liaison & Coordination with the officials of Ministry of Petroleum & Natural Gas for Various applications related to Sun Oil & natural Gas Division.

7. Liaison and Follow up with CPCSEA (MOEF) for approval of Protocols related to Animal experimentation.

8. Liaison and Follow up with NPPA from 2010-2015

9. Liaison and Follow up with Department of Pharmaceuticals from 2010-2015

10. Representing organization in various Court Matters.

11. Liaison and Follow up with Directorate General of Foreign Trade regarding Advance license and Import of items in the negative list, clearance of shipping bills.

12.To liaise with officials of CDSCO from grass root to top level.

13. To prepare a strategy to ensure timely and smooth movement of applications for New Drugs, Subsequent New Drugs and Fixed Dose combinations.

14. Oversee the applications for Registration for import  of Drugs and Import license thereof with timely approval/sanction.

15. To review documents for applications for approval of New Drugs, Subsequent New Drugs, Fixed Dose combinations and RC`s.

16.   To identify, select CRO`s for BA/BE/Clinical Trials and allocate studies accordingly.

17.   To negotiate total trial cost for BA/BE and Clinical Trials.

18.   To review protocols for BA/BE  and Clinical Trials.

19.   To conduct audits where trials are undertaken.

20.   To ensure timely submission of BA/BE and Clinical Trial reports to DCGI office.

21.   To represent Company in Subject Expert Committee meetings held in DCGI office.

22.   To ensure timely sanction of Test Licenses and NOC`s from DCGI/Zonal Office.

23.   To negotiate price of Innovator Drug and see to its timely import.

24.   To coordinate with factory QA/QC for preparation of documents as per Regulatory guidelines.

25.   To provide Management with latest inputs regarding approvals and sanctions in DCGI office.

26.   To provide minutes of the Subject Expert Committee Meetings/Agendas.

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Designation: Head/GM - DRA

Experience: 15+, 5 yrs exp into liasioning 

Location: New Delhi

Resposibilities:

1. Liaison and Coordination at CDSCO for approval of various applications related to IND, New Drugs, Subsequent New Drugs, Fixed Dose Combinations, BE for Export, Import, Medical Device and Biologicals. Inclusion of various proposals in different expert committee meetings.

2. Liaison and Coordination with Department of Biotechnology for the approval of various applications related to Bio-Similars.

3. Liaison and Coordination with the Directorate of Science and Industrial Research for approval & Recognition of In House R&D Centers and certification of their expenses

4. Liaison and Coordination with Central & Regional FSSAI for various applications related to product approvals and licenses.

5. Liaison and Coordination with the Officials of Ministry of Health & Family Welfare regarding matters related to Government Policies

6. Liaison & Coordination with the officials of Ministry of Petroleum & Natural Gas for Various applications related to Sun Oil & natural Gas Division.

7. Liaison and Follow up with CPCSEA (MOEF) for approval of Protocols related to Animal experimentation.

8. Liaison and Follow up with NPPA from 2010-2015

9. Liaison and Follow up with Department of Pharmaceuticals from 2010-2015

10. Representing organization in various Court Matters.

11. Liaison and Follow up with Directorate General of Foreign Trade regarding Advance license and Import of items in the negative list, clearance of shipping bills.

12.To liaise with officials of CDSCO from grass root to top level.

13. To prepare a strategy to ensure timely and smooth movement of applications for New Drugs, Subsequent New Drugs and Fixed Dose combinations.

14. Oversee the applications for Registration for import  of Drugs and Import license thereof with timely approval/sanction.

15. To review documents for applications for approval of New Drugs, Subsequent New Drugs, Fixed Dose combinations and RC`s.

16.   To identify, select CRO`s for BA/BE/Clinical Trials and allocate studies accordingly.

17.   To negotiate total trial cost for BA/BE and Clinical Trials.

18.   To review protocols for BA/BE  and Clinical Trials.

19.   To conduct audits where trials are undertaken.

20.   To ensure timely submission of BA/BE and Clinical Trial reports to DCGI office.

21.   To represent Company in Subject Expert Committee meetings held in DCGI office.

22.   To ensure timely sanction of Test Licenses and NOC`s from DCGI/Zonal Office.

23.   To negotiate price of Innovator Drug and see to its timely import.

24.   To coordinate with factory QA/QC for preparation of documents as per Regulatory guidelines.

25.   To provide Management with latest inputs regarding approvals and sanctions in DCGI office.

26.   To provide minutes of the Subject Expert Committee Meetings/Agendas.