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HomeCompaniesHcfa Fa Us2 Oraclecloud Com CX 5001Executive, 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

FieldValue
CompanyHcfa Fa Us2 Oraclecloud Com CX 5001
TitleExecutive, Regulatory Affairs
Normalized title-
Department / teamRegulatory Affairs
LocationGujarat, IN, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-05-19 / 2026-05-31
Changed / last seen2026-06-03 / 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
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City jobsActive postings in Gujarat.Open
Department jobsActive postings in Regulatory Affairs.Open
Work model jobsActive On Site postings.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 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 ID8c08302dbb290c11830bc262e589bee5f2a2569b
Org ID822a1eaf-b950-4323-90f0-79f735f12603
Source ID55674fbb-0c45-4fea-a514-ebaecaf9c870
Board ID55674fbb-0c45-4fea-a514-ebaecaf9c870
Provideroracle_hcm
Provider Job Key7981
TitleExecutive, Regulatory Affairs
Normalized Title
Statusactive
Activeyes
Location TextShapath, Ahmedabad, Gujarat, IN
DepartmentRegulatory Affairs
Team
Employment Typefull_time
Workplace Typeon_site
Remote Policy
CountryUnited States
RegionIN
CityGujarat
Salary RawDescription 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 URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7981
Apply URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7981
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 At2026-06-03 11:26:36Z
Inactive At
Source Posted At2026-05-19 09:38:09Z
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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Native Structured
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