Job Title
Executive
Job Grade
G12A
Department
India Regulatory Affairs
Location:
Tandalja-Baroda
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.
- Review advertisement of Consumer Healthcare Products and respond to the queries raised by ASCI.
- Evaluation and submission of application for grant of Registration Certificate to Legal Metrology.
- Checking of updates on the government regulatory sites.
Work Conditions
Physical Requirements:
Travel Estimate
Only if required
Education and Job Qualification
M. Pharm
Experience
2- 10 year's experience required in Regulatory Affairs for India Market.
