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Manager - 2

3 months ago

Vadodara, India SUN PHARMA Full time
Job Title:
Manager 2
Job Grade:
G11A
Department:
India Regulatory Affairs
Sub-function:
Corporate Relations
Manager’s Job Title:
Senior Manager - 1
Skip Level Manager’s 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.