Regulatory Operations Associate

Employment Type

: Full-Time


: Miscellaneous

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Job Description: Maintain Safety tracker, confirm IND Safety report receipt, processing, eCTD publishing, tracking, and archiving for safety reports and investigator submissions. Review and publish Chemistry Manufacturing and related documents, Granular clinical study reports, Preclinical reports, Annual reports, Non-clinical Reports, Investigational product dossiers to ensure all these finalized documents meet company specifications and FDA guidelines. Travel and relocation possible to unanticipated client locations throughout the U.S. for all the positions.

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