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Job for experienced candidates in USV Limited | Require Assistant Manager - Regulatory Affairs (US)

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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)

Job description

  • 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

Candidate Profile
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.

Additional Information:
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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