Job for experienced candidates in USV Limited | Require Assistant Manager - Regulatory Affairs (US)
USV is aleading healthcare company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Biosimilars. 68% of our business is contributed by India Operations and the rest by export of APIs and Generics.
USV is a 48 year old healthcare company which began as a joint venture with USV&P Inc, a subsidiary of Revlon. Product range consists of Generics, Active Pharmaceutical Ingredients and Biotherapeutics that are manufactured in our modern cGMP compliant plants located in India.
Post: Assistant Manager - Regulatory Affairs (US)
Regulatory support and review for pre-filing and development documentation
Coordination with internal and external stakeholders for regulatory filing related documentation
Review, compilation and authoring of Sterility Assurance and Sterile Process Validation
Review of plant and R&D documentation such as BMR, BPR, Specifications etc
Authoring, compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier
Post approval filing such as supplement and annual report
The candidate should be a BPharm/ MPharm (preffered), with 6+ years experience in sterile formulation filings for US markets.
He/She should be well-versed with the Sterility Assurance Package as well as the requirements for US market.
Apart from the above, the person should be a good communicator, detail oriented and assertive.
Experience: 6+ years
Location: Govandi, Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/Healthcare/Clinical research
Functional Area: DRA
End Date: 9th Feb., 2014
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