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Open nowPosted 8 days ago

Executive, Regulatory Operations (eCTD Publishing)

Amneal India91 open roles

Where
Ahmedabad City, Gujarat, India
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Your applicationOpen nowExecutive, Regulatory Operations (eCTD Publishing)Amneal India · Ahmedabad City, Gujarat, India

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The clock on this job

Early applications get read.

13.5% of postings close within 7 days. Measured by our own scanner across the market. Amneal India postings stay open a median of 6 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.6%3 days
  3. 13.5%7 days
  4. 21.8%14 days
  5. 36.6%30 days
  6. 58.9%60 days
This job: posted 8 days ago

Amneal India median: 6 days open

The posting

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.

Qualifications

Education:

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

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