Home › Companies › Hcfa Fa Us2 Oraclecloud Com CX 5001 › Executive/Sr. Executive, Regulatory Operations
Executive/Sr. Executive, Regulatory Operations
Hcfa Fa Us2 Oraclecloud Com CX 5001 · Shapath, Ahmedabad, Gujarat, IN · Active · Oracle Recruiting Cloud / Fusion HCM
Job facts
| Field | Value |
|---|---|
| Company | Hcfa Fa Us2 Oraclecloud Com CX 5001 |
| Title | Executive/Sr. Executive, Regulatory Operations |
| Normalized title | - |
| Department / team | Regulatory Affairs |
| Location | Gujarat, IN, United States |
| Work model | - |
| Employment type | Full Time |
| Salary | - |
| Status | active |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
| Posted / first seen | 2026-05-25 / 2026-05-31 |
| Changed / last seen | 2026-06-02 / 2026-06-06 |
Related slices
| Page | What it contains | Open |
|---|---|---|
| Company jobs | Active postings from Hcfa Fa Us2 Oraclecloud Com CX 5001. | Open |
| Company breakdowns | Role, location, ATS, and work model facets for this company. | Open |
| ATS provider jobs | Active postings observed through Oracle Recruiting Cloud / Fusion HCM. | Open |
| Provider filtered search | The same provider as a filtered job collection. | Open |
| City jobs | Active postings in Gujarat. | Open |
| Department jobs | Active postings in Regulatory Affairs. | Open |
| Lifecycle events | Open, update, close, and reopen events for this posting. | Open |
| Original posting | Canonical source or apply URL captured from the ATS. | Open |
Linked records
| Company | Hcfa Fa Us2 Oraclecloud Com CX 5001 |
| Source | 55674fbb-0c45-4fea-a514-ebaecaf9c870 |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
Description
Description
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
Education:
B. Pharm M. Pharm Experience:
3 - 4 Years Specialized Knowledge: Licenses:
Full job record
| Job ID | 5eef833dce157ce5d943be43cf19ef2e921eb47e |
| Org ID | 822a1eaf-b950-4323-90f0-79f735f12603 |
| Source ID | 55674fbb-0c45-4fea-a514-ebaecaf9c870 |
| Board ID | 55674fbb-0c45-4fea-a514-ebaecaf9c870 |
| Provider | oracle_hcm |
| Provider Job Key | 7710 |
| Title | Executive/Sr. Executive, Regulatory Operations |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | Shapath, Ahmedabad, Gujarat, IN |
| Department | Regulatory Affairs |
| Team | — |
| Employment Type | full_time |
| Workplace Type | — |
| Remote Policy | — |
| Country | United States |
| Region | IN |
| City | Gujarat |
| Salary Raw | Description 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 Education: B. Pharm M. Pharm Experience: 3 - 4 Years Specialized Knowledge: Licenses: |
| Salary Min | — |
| Salary Max | — |
| Salary Currency | — |
| Salary Period | — |
| Source URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7710 |
| Apply URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7710 |
| First Seen At | 2026-05-31 18:02:43Z |
| Last Seen At | 2026-06-06 20:23:04Z |
| Last Checked At | 2026-06-06 20:23:04Z |
| Last Changed At | 2026-06-02 11:26:12Z |
| Inactive At | — |
| Source Posted At | 2026-05-25 08:08:43Z |
| Source Updated At | — |
| Raw Payload Uri | s3://job-postings-prod-raw-590183727216/raw/provider=oracle_hcm/board=hcfa.fa.us2.oraclecloud.com|CX_5001/date=2026-06-06/2026-06-06T20-22-52-037Z-c8b76f7dadd2fd84e1ac9b9023fee1f40f3de46a882ea2c2b3ab7fb496a86529.json |
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