Amneal Pharma Job Vacancy for Regulatory Affairs

Amneal  Pharma Job Vacancy for Regulatory Affairs 

Amneal Pharma Job Vacancy for Regulatory Affairs

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, 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 SUGAM portal.

3. Prepare, review and compile BE & CT NOC application and submit online on 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 preparing, reviewing and submitting 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