Manager – Regulatory Affairs | Sun Pharma | Vadodara

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Job Overview

  • Date Posted
    June 2, 2023
  • Location (State / UT)
  • Expiration date
    June 29, 2024
  • Experience
    9 Years, 14 Years
  • Gender
    Any
  • Desired Qualification
    Master’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.