Manager-India Regulatory Affairs

Hi,

We are having an opening for Manager-IRA at our Baroda location.

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.

Education : M. Pharm

Experience : 5- 10 years experience required in Regulatory Affairs for India Market.