Amneal Pharma Job Opening For Regulatory Affairs Department - Job Availables

Amneal Pharma Job Opening For Regulatory Affairs Department - Job Availables

We at Amneal looking for Regulatory Affairs-US Market (OSD-Post Approval) at Ahmedabad

Function: RA-Post Approval (OSD-US Market)

Position: Manager

Experience: 9-16 Years

Job Responsibilities:

1. Extensive knowledge of ANDA submission activities and post approval procedures.

2. API DMF review with respect to USFDA regulatory requirement. 3. Thorough knowledge of solid oral dosage form and manufacturing process

4. Ability to assess the change cases with respect to post approval USFDA guidance and knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling

5. Compilation of the Annual Report and ensuring its submission as per stipulated timeline.

6. Ensure the no delay in submission always keen to adopt first to file approach.

7. Ensure better management of major supplements submissions.

8. High quality review of entire submission package to avoid any major deficiencies.

9. Maintain regulatory information as per current department practice. 

10. Coordination with Cross Functional teams for the documents availability.

Interested candidates may share CV at kavitriy@amnealindia.com