Home › Companies › Hcfa Fa Us2 Oraclecloud Com CX 5001 › Executive, Regulatory Affairs
Executive, Regulatory Affairs
Hcfa Fa Us2 Oraclecloud Com CX 5001 · Shapath, Ahmedabad, Gujarat, IN · On Site · Active · Oracle Recruiting Cloud / Fusion HCM
Job facts
| Field | Value |
|---|---|
| Company | Hcfa Fa Us2 Oraclecloud Com CX 5001 |
| Title | Executive, Regulatory Affairs |
| Normalized title | - |
| Department / team | Regulatory Affairs |
| Location | Gujarat, IN, United States |
| Work model | On Site |
| Employment type | Full Time |
| Salary | - |
| Status | active |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
| Posted / first seen | 2026-05-19 / 2026-05-31 |
| Changed / last seen | 2026-06-03 / 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 |
| Work model jobs | Active On Site postings. | 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
Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Drafting of the Annual Report with required submission data as per USFDA guidance. Preliminary review of entire submission package. Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions. Coordination with Cross Functional teams for the documents availability as per regulatory submission plan. Ensure the no delay in drafting and compiling the regulatory submission. Maintain regulatory information as per allocated task. Having good Regulatory CTD modules drafting & preliminary review skills.
Qualifications
Education: B. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 5 years or more in 5 - 8 Years Specialized Knowledge: Licenses:
Full job record
| Job ID | 8c08302dbb290c11830bc262e589bee5f2a2569b |
| 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 | 7981 |
| Title | Executive, Regulatory Affairs |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | Shapath, Ahmedabad, Gujarat, IN |
| Department | Regulatory Affairs |
| Team | — |
| Employment Type | full_time |
| Workplace Type | on_site |
| Remote Policy | — |
| Country | United States |
| Region | IN |
| City | Gujarat |
| Salary Raw | Description Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to preliminary review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Drafting of the Annual Report with required submission data as per USFDA guidance. Preliminary review of entire submission package. Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions. Coordination with Cross Functional teams for the documents availability as per regulatory submission plan. Ensure the no delay in drafting and compiling the regulatory submission. Maintain regulatory information as per allocated task. Having good Regulatory CTD modules drafting & preliminary review skills. Qualifications Education: B. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 5 years or more in 5 - 8 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/7981 |
| Apply URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7981 |
| 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 | 2026-06-03 11:26:36Z |
| Inactive At | — |
| Source Posted At | 2026-05-19 09:38:09Z |
| 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 |
Event Fields
{
"content_hash": "03806b26e71880b55ef7fc19a31b5ec283b93b7266ce41c3bf18b22b1bbec9a2",
"source_hash": "4948ba846b67863fc122f05917c7d22ce6b59e266f0fbc2a001ff36c5e85fda9",
"last_changed_at": "2026-06-03T11:26:36.724Z",
"active_status": "active"
}Parsed Structured
{
"language": "en",
"location": {
"raw": "Shapath, Ahmedabad, Gujarat, IN",
"city": "Gujarat",
"region": "IN",
"country": "United States",
"is_remote": false,
"confidence": 0.9
},
"salary_max": null,
"salary_min": null,
"inferred_at": "2026-06-06T20:23:04.080Z",
"launch_scope": {
"reason": "english_us_canada",
"included": true,
"language": "en",
"location": {
"raw": "Shapath, Ahmedabad, Gujarat, IN",
"city": "Gujarat",
"region": "IN",
"country": "United States",
"is_remote": false,
"confidence": 0.9
},
"countries": [
"United States"
]
},
"remote_policy": null,
"salary_period": null,
"workplace_type": "on_site",
"salary_currency": null
}Extensions
{}Native Structured
{
"detail": {
"Id": "7981",
"Title": "Executive, Regulatory Affairs",
"media": [],
"skills": [
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
},
{
"Skill": null,
"SectionName": "Skills"
}
],
"JobType": null,
"Category": "Regulatory Affairs",
"JobGrade": null,
"JobLevel": null,
"JobShift": null,
"WorkDays": null,
"WorkHours": null,
"WorkYears": null,
"Department": null,
"HotJobFlag": false,
"StudyLevel": "Master's Degree",
"WorkMonths": null,
"WorkerType": null,
"GeographyId": 300000074184362,
"JobFamilyId": 300000015541102,
"JobFunction": "Regulatory & Clinical Affairs",
"JobSchedule": "Full time",
"BusinessUnit": null,
"ContractType": null,
"Organization": null,
"TrendingFlag": true,
"workLocation": [
{
"Country": "IN",
"Region1": null,
"Region2": "Gujarat",
"Region3": null,
"Building": null,
"Latitude": "23.02213",
"Longitude": "72.52506",
"LocationId": 300000116226110,
"PostalCode": "380015",
"TownOrCity": "Ahmedabad",
"AddressLine1": "Shapath-V, Near Hotel Crown Plaza",
"AddressLine2": "12th Floor & 18th Floor, S.G. Highway",
"AddressLine3": null,
"AddressLine4": null,
"LocationName": "Shapath"
}
],
"ContentLocale": "en",
"HiringManager": null,
"LegalEmployer": null,
"RequisitionId": 300000240728285,
"WorkplaceType": "On-site",
"BusinessUnitId": 100000000147208,
"OrganizationId": 100000000147208,
"GeographyNodeId": 100000310315545,
"JobFunctionCode": "RACA",
"LegalEmployerId": 300000008253178,
"PrimaryLocation": "Ahmedabad City, Gujarat, India",
"RequisitionType": "India - Regular",
"NumberOfOpenings": null,
"WorkplaceTypeCode": "ORA_ON_SITE",
"BeFirstToApplyFlag": false,
"otherWorkLocations": [],
"secondaryLocations": [],
"ExternalContactName": null,
"ShortDescriptionStr": "Executive/Sr. Executive Level – RA SLCM Post approval Role",
"ExternalContactEmail": null,
"ExternalPostedEndDate": "2026-06-14T18:30:00+00:00",
"OtherRequisitionTitle": null,
"requisitionFlexFields": [],
"ApplyWhenNotPostedFlag": null,
"DomesticTravelRequired": null,
"ExternalDescriptionStr": "<ul><li><span data-teams=\"true\">Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.</span></li><li><span data-teams=\"true\">Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.</span></li><li><span data-teams=\"true\">Ability to <strong>preliminary review the change cases</strong> with respect to ICH quality / post approval USFDA guidance and aware for <strong>Post approval submission guideline</strong> and procedure for Annual report/CBE 0/CBE 30 and PAS filling </span></li><li><span data-teams=\"true\">Drafting of the <strong>Annual Report</strong> with required submission data as per USFDA guidance.</span></li><li><span data-teams=\"true\"><strong>Preliminary review</strong> of entire submission package.</span></li><li><span data-teams=\"true\">Awareness about the FDA recommendation on the commercial <strong>marketing status notification</strong> submission in terms of content and time frames and submissions.</span></li><li><span data-teams=\"true\">Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.</span></li><li><span data-teams=\"true\">Ensure the no delay in drafting and compiling the regulatory submission.</span></li><li><span data-teams=\"true\">Maintain regulatory information as per allocated task.</span></li><li><p><span data-teams=\"true\">Having good Regulatory CTD modules drafting & preliminary review skills.</span></p><p> </p></li></ul>",
"ObjectVerNumberProfile": "2",
"PrimaryLocationCountry": "IN",
"CorporateDescriptionStr": "",
"ExternalPostedStartDate": "2026-05-19T09:38:09+00:00",
"ExternalQualificationsStr": "<html><b>Education:</b><ul><li>B. Pharm B. Pharm - Required</li></ul><ul><li>M. Pharm M. Pharm - Preferred</li></ul> <b>Experience:</b><ul><li>5 years or more in 5 - 8 Years</li></ul> <b>Specialized Knowledge:</b><b> Licenses:</b></html>\n",
"InternalQualificationsStr": "<html><b>Education:</b><ul><li>B. Pharm B. Pharm - Required</li></ul><ul><li>M. Pharm M. Pharm - Preferred</li></ul> <b>Experience:</b><ul><li>5 years or more in 5 - 8 Years</li></ul> <b>Specialized Knowledge:</b><b> Licenses:</b></html>\n",
"OrganizationDescriptionStr": "",
"primaryLocationCoordinates": [
{
"Latitude": "23.24082",
"Longitude": "72.63733",
"CountryCode": "IN",
"GeographyId": 300000074184362,
"GeographyNodeId": 100000310315545
}
],
"ExternalResponsibilitiesStr": "",
"InternalResponsibilitiesStr": "",
"InternationalTravelRequired": null
},
"list_job": {
"Id": "7981",
"Title": "Executive, Regulatory Affairs",
"JobType": null,
"Distance": 1779148800000,
"JobShift": null,
"Language": "US",
"WorkDays": null,
"JobFamily": null,
"Relevancy": 3,
"WorkHours": null,
"Department": null,
"HotJobFlag": false,
"PostedDate": "2026-05-19",
"StudyLevel": null,
"WorkerType": null,
"GeographyId": 300000074184362,
"JobFunction": null,
"JobSchedule": null,
"BusinessUnit": null,
"ContractType": null,
"ManagerLevel": null,
"Organization": null,
"TrendingFlag": true,
"workLocation": [
{
"Country": "IN",
"Region1": null,
"Region2": "Gujarat",
"Region3": null,
"Building": null,
"Latitude": 23.02213,
"Longitude": 72.52506,
"LocationId": 300000116226110,
"PostalCode": "380015",
"TownOrCity": "Ahmedabad",
"AddressLine1": "Shapath-V, Near Hotel Crown Plaza",
"AddressLine2": "12th Floor & 18th Floor, S.G. Highway",
"AddressLine3": null,
"AddressLine4": null,
"LocationName": "Shapath"
}
],
"LegalEmployer": null,
"MediaThumbURL": null,
"WorkplaceType": "On-site",
"BusinessUnitId": 100000000147208,
"OrganizationId": 100000000147208,
"PostingEndDate": null,
"LegalEmployerId": 300000008253178,
"PrimaryLocation": "Ahmedabad City, Gujarat, India",
"WorkDurationYears": null,
"WorkplaceTypeCode": "ORA_ON_SITE",
"BeFirstToApplyFlag": false,
"WorkDurationMonths": null,
"otherWorkLocations": [],
"secondaryLocations": [],
"ShortDescriptionStr": "Executive/Sr. Executive Level – RA SLCM Post approval Role",
"requisitionFlexFields": [],
"DomesticTravelRequired": null,
"PrimaryLocationCountry": "IN",
"ExternalQualificationsStr": null,
"ExternalResponsibilitiesStr": null,
"InternationalTravelRequired": null
},
"detail_meta": {
"url": "https://hcfa.fa.us2.oraclecloud.com/hcmRestApi/resources/latest/recruitingCEJobRequisitionDetails?expand=all&onlyData=true&finder=ById;Id=%227981%22,siteNumber=CX_5001",
"http_status": 200,
"content_type": "application/json",
"response_bytes": 5973
},
"detail_errors": []
}Get this page with API
Rendered from the bluedoor Job Postings API. Reproduce it:
GET https://api.bluedoor.sh/job-postings/v1/jobs/8c08302dbb290c11830bc262e589bee5f2a2569b?include=descriptionJSONGET https://api.bluedoor.sh/job-postings/v1/orgs/822a1eaf-b950-4323-90f0-79f735f12603JSONGET https://api.bluedoor.sh/job-postings/v1/sources/55674fbb-0c45-4fea-a514-ebaecaf9c870JSONGET https://api.bluedoor.sh/job-postings/v1/jobs/8c08302dbb290c11830bc262e589bee5f2a2569b/eventsJSON