Manager - 1
SUN PHARMA
Date: 1 week ago
City: Vadodara, Gujarat
Contract type: Full time
Job Title
Manager-1
Job Grade
G10
Department
India Regulatory Affairs
Sub-function
Corporate Relations
Location:
Tandalja(Vadodara)
Job Summary
Regulatory submissions of drugs in India.
Area of Responsibility
Only if required
Education and Job Qualification
M. Pharm
Experience
5- 10 years’ experience required in Regulatory Affairs for India Market.
Manager-1
Job Grade
G10
Department
India Regulatory Affairs
Sub-function
Corporate Relations
Location:
Tandalja(Vadodara)
Job Summary
Regulatory submissions of drugs 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 bioequivalence study / clinical trial permission / licence to import drug for these studies from DCGI.
- Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI.
- Evaluation and submission of application on online portal for NCE molecules.
- Evaluation and submission of application on online portal for global clinical trial applications.
- Evaluation of the CMC documents/CT-BE documents and other documents that need to be submitted with the applications and coordinating with the respective team for finalization.
- To do literature search, to make rationale for products to be filed to DCGI.
- Reviewing Draft Gazette notification related to regulatory domain and sharing comments on the same.
- Submission of samples to IPC for testing as part of domestic manufacturing and marketing application.
Only if required
Education and Job Qualification
M. Pharm
Experience
5- 10 years’ experience required in Regulatory Affairs for India Market.
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