ROLE
– Prepare, compile, and publish high quality eCTD sequences for ANDAs/NDAs/Amendments/Supplements in alignment with USFDA eCTD technical specifications and ICH guidelines.
– Execute precise PDF publishing standards: pagination, bookmarks, hyperlinks, table of contents, headers/footers, legibility, OCR, and accessibility compliance.
– Perform end to end pre-publish checks and validations; resolve all technical errors/warnings; troubleshoot link/file/path, STF, and schema issues prior to finalization.
– Coordinate cross functionally with Regulatory, CMC, Nonclinical/Clinical, and Labeling teams to secure submission ready documents on time.
– Prepare and submit through FDA ESG, monitor and interpret ACK1/ACK2/ACK3, and rapidly address transmission errors with IT/ESG support.
– Monitor and implement updates to USFDA eCTD Technical Conformance Guide, regional Module 1 specs, validation rules, and eCTD v4.0 transition requirements.

REQUIREMENTS
– Having good knowledge of the regulatory guidelines related to eCTD publishing and submissions, mainly ICH M4, M8 and FDA eCTD guidance.