Senior Officer, Regulatory Operations (eCTD Publishing)
Senior Officer, Regulatory Operations (eCTD Publishing)
Refined job description
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.
– Establish timelines and critical paths for sequence readiness; escalate any risks/hurdle with mitigations during publishing process.
– Support health authority communications: track correspondence, upload/view responses in the correct leaf nodes, and manage meeting packages and minutes in eCTD format.
– Conduct root‑cause analysis for recurring validation
Full job description
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 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 mitigations during publishing process.
Support health authority communications: track correspondence, upload/view responses in the correct leaf nodes, and manage meeting packages and minutes in eCTD format.
Conduct root‑cause analysis for recurring validation failures; implement corrective/preventive actions (CAPA) to enhance first‑time‑right submissions.