Executive, Regulatory Operations (eCTD Publishing)
AhmedabadFull-time5–8 yrsPosted 1 week ago
Senior legal role at Hcfa in Ahmedabad. Needs 5–8 years and a B.Pharm or M.Pharm.
About the role
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.
What you'll do
- 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
- 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
What you need
- Regulatory affairs
- Compliance
- Root cause analysis