Amneal Pharma looking for Regulatory Affairs professionals.
Request to find below the required details:
– Experience: 08-13 Years
– Position: Manager
– Job Location: Ahmedabad
Job Role:
1. Ensuring submission to DCGI, and LFDA in compliance with current regulatory guidelines.
2. Performing Indian Regulatory legal activities (DCGI and LFDA).
Prepare, review, compile Manufacturing & Marketing application and submit online on the SUGAM portal.
3. Prepare, review and compile BE & CT NOC applications and submit them online on the SUGAM portal.
4. Prepare and Review Form 29 NOC (CT 10, CT 12, and CT 13), Form 29, Form 10 (import license), LFDA, CDTL NOC, CDTL report.
5. Review data integratory for all submitted documents.
6. Ensuring all regulatory compliance for submission of application.
7. To evaluate queries raised by Regulatory Authority and prepare, review and submit the Query Response.
8. Review all the technical documents required for post-approval changes.
Interested candidates may share their updated CV at kavitriy@amnealindia.com