Executive/Sr. Executive, Regulatory Operations
Amneal Pharmaceuticals
Date: 2 hours ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
QUALIFICATIONS
- Having good knowledge of the regulatory guidelines related to eCTD publishing and submissions, mainly ICH M4, M8 and FDA eCTD guidance.
- 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.
QUALIFICATIONS
- B. Pharm
- M. Pharm
- 3 - 4 Years
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