Manager-India Regulatory Affairs

Job Description

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.