Manager - 1

Job Description

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Manager - 1 Date: Jun 24, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd 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 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. Travel Estimate Only if required Education and Job Qualification M. Pharm Experience 5- 10 years’ experience required in Regulatory Affairs for India Market. Apply Now » Apply Now Start applying with LinkedIn Please wait...