Job Overview
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Date PostedJune 2, 2023
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Location (State / UT)
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Expiration dateJune 29, 2024
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Experience9 Years, 14 Years
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GenderAny
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Desired QualificationMaster’s Degree
Job Description
Job Summary:
Regulatory submissions of Drugs and Food Products in India.
Area Of Responsibility:
- Evaluation and submission of application for getting domestic manufacturing permission from DCGI. Also, evaluating enclosures to be submitted with the application.
- 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-11/14/15.
- 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 10.
- Reviewing Draft Gazette notifications related to the scope of the department and sharing comments on the same.
- Evaluation and submission of response to the market complaints raised by a regulatory authority.
- Evaluation and submission of recall notifications.
- Review advertisements of Consumer Healthcare Products and respond to the queries raised by ASCI.
- Evaluation and submission of application to FSSAI for New Ingredient Approval/Unapproved Claims.
- Evaluation and submission of application for grant of License to manufacture food product to FSSAI.
- Review of artworks of food products as per FSSAI Regulations.
- Submit Annual Return against the available FSSAI license.
- Evaluation and submission of application for grant of Registration Certificate to Legal Metrology.
Desired Candidate Profile:
Education: M. Pharm.
Experience: Minimum 10 years experience required in Regulatory Affairs for Domestic Market.