Role summary: As a regulatory affairs specialist responsible for authoring, compiling, reviewing, and submitting regulatory submission in compliance with FDA and ICH requirements and according to SOFIE’s project timelines. These submissions include but are not limited to radiopharmaceutical INDs, NDAs, ANDAs, DMFs, Amendments, Supplements, Alerts and Annual Reports. This position will be performed remotely. List of responsibilities Responsible for preparation, compilation, review and submission of new NDAs, ANDAs, DMFs, INDs, Amendments, Supplements and Annual Reports for FDA submission Write related modules in support of regulatory filings as appropriate. Serve as a regulatory subject matter expert to the technica
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