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. Escalate the review findings to Manager, RA for a timely resolution. Review and implement RLD Labeling updates, prepare labeling submissions, and review promotional materials and submit to the FDA for review, as necessary. Initiate change control process and coordinate with other departments to ensure timely implementation of revised labeling. Prepare, review and submit eCTD submissions and SPLs. Proactively assess all submissions for GAP analysis and summarize a report for anticipated deficiencies prior to submission to the FDA. Work cross-functionally with other sites/CMOs, project management and R&D departments.
https://www.indeed.com/viewjob?t=regulatory+publishing+specialist&jk=7c1c884792e99959&_ga=2.63605549.34278709.1543464324-1408033885.1530798869
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