SUN PHARMA | Senior Executive-IRA | vadodara
2 weeks ago
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.
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