Title:  Senior Manager 2

 1.To manage the proper functioning of Site Regulatory department and co-ordinate with other department of the plant and corporate regulatory for compilation of data required for Filing of Drug Master Files in USA, Europe, Canada, and other countries, during DMF submissions/Query response.

2.Annual Updation / Renewals of DMF’s [USDMF, CEP, Canada DMF, MRP, DCP procedures]

3.Updation of various changes in the DMF in co-ordination with CRA.

4.Response to the deficiencies received on DMF from regulatory authorities with CRA.

5.Customer queries –Responses in co-ordination with CRA.

6.Review and Approval of Change Control, Annual Product Review.

7.Review and Approval of Specifications & ATP's

8.To inform changes/modification/incidents/investigations having regulatory impact to CRA.

9.Identify the training need & organize for the training to concerned group in Regulatory & other departments.

10. Preparation ,Review and approval of GMP documents.

11.Authorization for taking Extention for Change control on requirement.

12.Doing Change control closing in trackwise after filing and after getting approval

13.To highlight quality related problems immediately on observation.

14.Preparation and review of GMP documents related to activities.

15.To follow safety & use of required personal protective equipment during day to day activities