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Senior Executive-IRA

4 weeks ago

Vadodara, India SUN PHARMA Full time

Hi,

We are having an opening for Senior Executive-IRA at our Baroda location.


Position: Senior Executive

Location: Baroda

Company: Sun Pharmaceutical Industries Ltd.


Job Summary :

Regulatory submissions of drugs and medical devices 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 domestic manufacturing and marketing permission from DCGI.
  • Evaluation and submission of applications on online portal for import registration/import license of drugs and medical devices in India.
  • Evaluation of the documents that need to be submitted with the applications and coordinating with the respective team for finalization.
  • Evaluation and submission of application for getting BE permission for export registration.
  • Evaluation and submission of application for getting permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13.
  • Evaluation and submission of application for getting permission to import drugs for examination, test or analysis in Form-11/Form CT-17.
  • Evaluation and submission of application for getting permission to import drugs in Form 8.
  • Evaluation and submission of applications for getting permission to import medical devices for examination test and analysis in MD-16.
  • Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same.
  • Evaluation and submission of response to the market complaints raised by regulatory authority.


Education : M. Pharm


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