Prepare the submissions for ANDAs, amendments, supplements, annual reports to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA.
https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=7c1c884792e99959&_ga=2.14934518.1969368399.1543686974-1024118673.1543686974
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