Senior Officer, Regulatory Operations (eCTD Publishing)

Amneal; India; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amneal is seeking a regulatory publishing specialist to prepare, compile, and publish high‑quality eCTD sequences for ANDAs/NDAs in alignment with USFDA and ICH guidelines. You will coordinate with Regulatory, CMC, and Clinical teams to ensure submission readiness.

The role requires meticulous attention to PDF publishing standards, pre‑publish validations, and rapid resolution of technical issues, while tracking ESG submissions and updates to eCTD specifications.

Qualifications

• Experience in regulatory document publishing (eCTD)
• Familiarity with USFDA eCTD specifications and ICH guidelines
• Experience coordinating cross-functional teams to meet submission timelines

Responsibilities

• Prepare, compile, and publish high-quality eCTD sequences for ANDAs/NDAs/Amendments/Supplements in alignment with USFDA eCTD technical specifications and ICH guidelines.
• Coordinate cross-functionally with Regulatory, CMC, Nonclinical/Clinical, and Labeling teams to secure submission-ready documents on time.
• Monitor and address transmission errors with IT/ESG support and ensure compliance with eCTD v4.0 transition requirements.

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; escalated 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