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HomeCompaniesHcfa Fa Us2 Oraclecloud Com CX 5001Executive/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

FieldValue
CompanyHcfa Fa Us2 Oraclecloud Com CX 5001
TitleExecutive/Sr. Executive, Regulatory Operations
Normalized title-
Department / teamRegulatory Affairs
LocationGujarat, IN, United States
Work model-
Employment typeFull Time
Salary-
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-05-25 / 2026-05-31
Changed / last seen2026-06-02 / 2026-06-06

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PageWhat it containsOpen
Company jobsActive postings from Hcfa Fa Us2 Oraclecloud Com CX 5001.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through Oracle Recruiting Cloud / Fusion HCM.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Gujarat.Open
Department jobsActive postings in Regulatory Affairs.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyHcfa Fa Us2 Oraclecloud Com CX 5001
Source55674fbb-0c45-4fea-a514-ebaecaf9c870
ATS providerOracle 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 ID5eef833dce157ce5d943be43cf19ef2e921eb47e
Org ID822a1eaf-b950-4323-90f0-79f735f12603
Source ID55674fbb-0c45-4fea-a514-ebaecaf9c870
Board ID55674fbb-0c45-4fea-a514-ebaecaf9c870
Provideroracle_hcm
Provider Job Key7710
TitleExecutive/Sr. Executive, Regulatory Operations
Normalized Title
Statusactive
Activeyes
Location TextShapath, Ahmedabad, Gujarat, IN
DepartmentRegulatory Affairs
Team
Employment Typefull_time
Workplace Type
Remote Policy
CountryUnited States
RegionIN
CityGujarat
Salary RawDescription 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 URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7710
Apply URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7710
First Seen At2026-05-31 18:02:43Z
Last Seen At2026-06-06 20:23:04Z
Last Checked At2026-06-06 20:23:04Z
Last Changed At2026-06-02 11:26:12Z
Inactive At
Source Posted At2026-05-25 08:08:43Z
Source Updated At
Raw Payload Uris3://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
Event Fields
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Extensions
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