Title: Manager - 2

Date: Jun 3, 2024

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd



Job Title:

Manager 2

Job Grade:

G11A


Department:

India Regulatory Affairs

Sub-function:

Corporate Relations


Managers Job Title:

Senior Manager - 1

Skip Level Managers Title:

Senior General Manager


No. of Direct Reports (if any)

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


8- 10 years experience required in Regulatory Affairs for India Market.