Regulatory Affairs Role - Labeling - US Market (2-8 yrs) Premium
6 months ago Marketing & Communication Hyderabad 29 views Reference: 33523Job 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.
- Apply
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]
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]
