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

4 months ago   Marketing & Communication   Hyderabad   17 views Reference: 33523
Job Details

- 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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Company Description
The company commenced operations in 198889 with a single unit manufacturing semi-synthetic penicillin (SSP) in Puducherry.[8] Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. Aurobindo Pharma also has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
Aurobindo Pharma features among the top 10 companies in India in terms of consolidated revenues.[5] Aurobindo exports to over 125 countries with more than 70% of its revenues derived out of international operations.
In 2014, Aurobindo purchased the generic operations of Actavis in 7 Western European countries for $41 million.[9][10]