AMNEAL PHARMA, openings in Regulatory Affair-OSD (US-Market) department at Ahmedabad location.

We are having openings in Regulatory Affair-OSD (US-Market) department at Ahmedabad location.

POSITION: Sr. Executive/Asst. Manager/Manager

Job Description:

*          Should be having good understanding of GDUFA process.

*          Should be able to coordinate with other depts. to finalize deficiency responses.

*          Should be a good technical writer.

*          Should be able to handle complete Type II API DMF Lifecycle (includes, Review of Original 

            DMF, DMF Amendments & Annual Reports).

*          Should be having good understanding of GDUFA process and electronic activities.

*          Should be able to handle post approval submissions like PAS, CBE-30, CBE-0, Annual  

            Reports.

*          Will work with Mfg., QA, QC & other plant functions.

*          Should be able to handle all electronic submission activities for ANDA life cycle.

*          Must be an expert of eCTD software

*          Should be able to handle complete US labeling activities including Labeling Modules                           Compilation and Review for Original ANDA, ANDA Amendments.

*          Finalization of US Labeling Artwork.

Interview Date & Time: will Inform

Please send your updated CV at kavitriy@amnealindia.com if interested to change

Dr. Kavitri Yadav

HR-Amneal Pharma

Ahmedabad