• Having good 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 exact 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