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Senior 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	Senior 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 Job Responsibility: Regulatory Affairs Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. Compile, prepare, review and submit IND, NDA and ANDA submissions along with associated Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions, lifecycle management, and deficiency responses to ensure timely approvals. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and FDA expectations. Drive first-cycle approval success, minimize deficiency rates, and ensure “Right First Time” submissions. Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND, Pre-NDA and EU scientific advisory meetings) to FDA on specific issues as needed for assigned projects. Ensure timely submission of all assigned projects. Work very closely with all relevant departments at the time of product initiations, R&D phase, NDA/ANDA Execution and after initiation of stability to ensure availability of all documents to ensure timely submissions. Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency. Evaluate post-approval change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS. Proactively raises major project issues to superior for resolution and agreement. Be flexible in timings and available for teleconferences as per US team schedule. Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies to avoid acceptable for filing issues. Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time. Responsibilities / Skills: Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. Excellent written (Technical writing) and verbal communication skills and interpersonal skills. Prior experience working with ANDAs, INDs, NDAs and FDA correspondences. Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. Ability to communicate effectively and collaboratively as part of a team in a respectful manner. Ability to interface with professionals domestically and abroad. Ability to work independently, self-starter. Working knowledge of ICH, FDA and 21 CFR regulations. Should archive and maintain all submissions in a systematic way. Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Maintain current knowledge of regulations and other issues that affect products and industry. Good problem solving skills and analytical ability. Aware of eCTD regulations and health authorities expectation. Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must. 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	6efd3787a584926d3559349e2bb4ae5553b4ebfb
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	8012
Title	Senior 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 Job Responsibility: Regulatory Affairs Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques. Compile, prepare, review and submit IND, NDA and ANDA submissions along with associated Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible. Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions, lifecycle management, and deficiency responses to ensure timely approvals. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met. Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and FDA expectations. Drive first-cycle approval success, minimize deficiency rates, and ensure “Right First Time” submissions. Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND, Pre-NDA and EU scientific advisory meetings) to FDA on specific issues as needed for assigned projects. Ensure timely submission of all assigned projects. Work very closely with all relevant departments at the time of product initiations, R&D phase, NDA/ANDA Execution and after initiation of stability to ensure availability of all documents to ensure timely submissions. Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency. Evaluate post-approval change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS. Proactively raises major project issues to superior for resolution and agreement. Be flexible in timings and available for teleconferences as per US team schedule. Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies to avoid acceptable for filing issues. Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time. Responsibilities / Skills: Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. Excellent written (Technical writing) and verbal communication skills and interpersonal skills. Prior experience working with ANDAs, INDs, NDAs and FDA correspondences. Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. Ability to communicate effectively and collaboratively as part of a team in a respectful manner. Ability to interface with professionals domestically and abroad. Ability to work independently, self-starter. Working knowledge of ICH, FDA and 21 CFR regulations. Should archive and maintain all submissions in a systematic way. Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department. Maintain current knowledge of regulations and other issues that affect products and industry. Good problem solving skills and analytical ability. Aware of eCTD regulations and health authorities expectation. Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must. 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/8012
Apply URL	https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/8012
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 09:36:53Z
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

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Parsed Structured

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Extensions

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Native Structured

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    "ExternalDescriptionStr": "<p><span lang=\"EN-US\"><strong>Job Responsibility: Regulatory Affairs&nbsp;</strong></span></p><p>&nbsp;</p><ul style=\"list-style-type: disc; padding-left: 24px;\"><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Must have expertise/prior experience in Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs either with Aseptic sterilization or Terminal sterilization or both techniques.&nbsp;</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Compile, prepare, review and submit IND, NDA and ANDA submissions along with associated Amendments to FDA with an overall objective to avoid major deficiencies and contribute to get approval within the shortest timeframes possible.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Develop and implement CMC regulatory strategies for IND/NDA and ANDA submissions, lifecycle management, and deficiency responses to ensure timely approvals.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Ensure high quality, compliance-driven submissions aligned with cGMP, ICH, and FDA expectations. Drive first-cycle approval success, minimize deficiency rates, and ensure “Right First Time” submissions.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Prepare and finalize controlled correspondence as well as Pre-submission meeting package (Pre-ANDA, Pre-IND, Pre-NDA and EU scientific advisory meetings) to FDA on specific issues as needed for assigned projects.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Ensure timely submission of all assigned projects. Work very closely with all relevant departments at the time of product initiations, R&amp;D phase, NDA/ANDA Execution and after initiation of stability to ensure availability of all documents to ensure timely submissions.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Assess the deficiency letter immediately after receipt from FDA, perform in-detail gap assessment and discuss with superiors to finalize the strategy to respond the deficiency.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Evaluate post-approval change controls and formulates strategies for correct filing categories, with minimal involvement of supervisor. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Proactively raises major project issues to superior for resolution and agreement.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Be flexible in timings and available for teleconferences as per US team schedule.&nbsp;</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Evaluate final compositions for IIG and Proportionality similar criteria’s and develop regulatory strategies to avoid acceptable for filing issues.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Review the API DMFs thoroughly and share the review comments to purchase department on-time. Follow up with purchase team or with DMF holder directly as needed to ensure compliance to provided comments on-time.</span></span></p></li></ul><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; text-align: justify;\">&nbsp;</p><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\"><strong>Responsibilities / Skills:</strong></span></span></p><ul style=\"list-style-type: disc; padding-left: 24px;\"><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Excellent written (Technical writing) and verbal communication skills and interpersonal skills.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Prior experience working with ANDAs, INDs, NDAs and FDA correspondences.</span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Ability to communicate effectively and collaboratively as part of a team in a respectful manner.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Ability to interface with professionals domestically and abroad.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Ability to work independently, self-starter.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Working knowledge of ICH, FDA and 21 CFR regulations.</span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Should archive and maintain all submissions in a systematic way.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Maintain current knowledge of regulations and other issues that affect products and industry.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Good problem solving skills and analytical ability.</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Aware of eCTD regulations and health authorities expectation.&nbsp;</span></span></p></li><li class=\"ortl-align-justify\"><p style=\"background-color: white; line-height: 115%; margin-bottom: 6pt; margin-right: 0cm; margin-top: 0cm; text-align: justify;\"><span style=\"color: black;\"><span lang=\"EN-US\" style=\"font-size: 11pt; line-height: 115%;\">Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Power-point, Outlook and Adobe Professional is a must.</span></span></p></li></ul>",
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