Job Title:

Manager-1

Job Grade:

G10

Department:

India Regulatory Affairs

Sub-function:

Corporate Relations

Location:

Tandalja(Vadodara)

 

 

 

 

Job Summary

Regulatory submissions of drugs in India.

Area of Responsibility

Evaluation of regulatory strategies for products to be registered in India.  Evaluation and submission of application on online portal for getting bioequivalence study / clinical trial permission / licence to import drug for these studies from DCGI. Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of application on online portal for NCE molecules. Evaluation and submission of application on online portal for global clinical trial applications. Evaluation of the CMC documents/CT-BE documents and other documents that need to be submitted with the applications and coordinating with the respective team for finalization. To do literature search, to make rationale for products to be filed to DCGI. Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same. Submission of samples to IPC for testing as part of domestic manufacturing and marketing application.

Travel Estimate

Only if required

Education and Job Qualification

M. Pharm

 

 

 

Experience

5- 10 years’ experience required in Regulatory Affairs for India Market.