Manager – IRA | Sun Pharma | Vadodara

Job Description

Position  Summary :

Regulatory submissions of drugs and medical devices in India.

Position: Manager

Location: Vadodara / Baroda

Role & Responsibilities:

• 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 advertisements 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.

Qualification: M.Pharma

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