HR at Aurobindo Pharma
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Regulatory Affairs Role - Labeling - US Market (2-8 yrs)
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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