* Having valuable knowledge of the regulatory guidelines related to eCTD publishing
and submissions, mainly ICH M4, M8 and FDA eCTD guidances.
* Prepare, compile, and publish high‑quality eCTD sequences for
ANDAs/NDAs/Amendments/Supplements in alignment with USFDA eCTD technical
specifications and ICH guidelines.
* Own Module 1 (US‑regional) requirements and ensure correct placement/metadata
for cover letters, forms (356h), labeling (SPL), REMS, correspondence, and
ESG submission properties.
* Ensure accuracy and consistency across Module 2 summaries and Module 3
(CMC/Quality), with correct granularity, file naming, and document locations
per eCTD backbone.
* 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.
* Manage lifecycle operations (new, replace, append, delete) with proper leaf
tracking and sequence continuity, maintaining audit trails and version
control.
* Define and maintain sequence metadata (submission type, sequence number,
submission description, related sequence references) with zero‑defect
accuracy.
* 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.
* Execute Study Tagging Files (STFs) where applicable; validate structure and
relationships for quality/nonclinical/clinical study sections.
* Establish timelines and critical paths for sequence readiness; escalate any
risks/hurdle with mitigati
📌 Senior Officer, Regulatory Operations (India)
🏢 Amneal
📍 India