20/07 Harika Namburi
HR at Aurobindo Pharma

Views:150 Applications:15 Rec. Actions:Recruiter Actions:0

Regulatory Affairs Role - Labeling - US Market (2-8 yrs) Premium

Hyderabad Job Code: 22518

Department : Regulatory Affairs, US Market

Role : Labeling

Experience : 2-8 years

Qualification : B. Pharm/M. Pharm

Job Description

- Review, Finalization and Compilation of Module-1 Documents for the filing of ANDAs and NDA.

- Amendments (Labeling / Gratuitous / Patent / Complete Responses) and Supplements (CBE and PAS) and Annual Reports.

- Initiation of WOS and WORs on Agile

- Review and Approval of WOLs on Agile

- Review and Approval of artworks and print proofs of commercial labeling on Agile.

- Drug Listing for the approved ANDAs.

- Review and Approval of WOLs on DAI.

- Review and Approval of change controls.

- Review of IID documents.

- Preparation the request for Preassigned ANDA number request.

- Preparation of controlled correspondence and citizen petitions.

- Daily monitoring of FDA site, Orange Book, DailyMed site and FDA petition Law Blog site.

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