Home › Companies › Hcfa Fa Us2 Oraclecloud Com CX 5001 › Assistant Manager, Regulatory Affairs

Assistant Manager, Regulatory Affairs

Hcfa Fa Us2 Oraclecloud Com CX 5001 · India; 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	Assistant Manager, 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	2026-05-25 / 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
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 Description: Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product development and lifecycle management. The role oversees preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications required for approvals from regulatory authorities. It contributes to monitoring regulatory developments, policy updates, and industry intelligence, evaluating their impact on regulatory strategies and organizational operations. The position coordinates regulatory communications, responses, and compliance documentation for interactions with health authorities. It also collaborates with cross-functional teams to strengthen regulatory governance, documentation control, and compliance monitoring, supporting timely approvals and sustainable regulatory alignment across markets. Essential Functions: Lead and review dossier compilation & publishing for complex submissions Oversee DMF compilation & review process and submission strategies Direct eCTD & electronic submissions across regions Manage post-submission management and health authority responses Ensure robust document version control & governance Monitor regulatory intelligence and assess strategic impact Drive regulatory & supplement reporting and lifecycle updates Coordinate regulatory & health authority management engagements Ensure inspection readiness for DMF and audit preparedness Apply risk identification & mitigation in regulatory planning Ensure sustained regulatory compliance across product lifecycle Lead quality & audit readiness initiatives Additional Responsibilities: Qualifications Education: B. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 8 years or more in 8 - 10 Years Specialized Knowledge: Licenses:

Full job record

Job ID	1ea9ee1a67575c1ffca8b8e5de343871d1b3f1b4
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	7887
Title	Assistant Manager, Regulatory Affairs
Normalized Title	—
Status	active
Active	yes
Location Text	India; 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 Description: Responsible for managing regulatory affairs activities and regulatory strategy execution to ensure compliance with global regulatory requirements, industry standards, and ethical practices throughout product development and lifecycle management. The role oversees preparation, review, and submission of regulatory dossiers, technical documentation, and product registration applications required for approvals from regulatory authorities. It contributes to monitoring regulatory developments, policy updates, and industry intelligence, evaluating their impact on regulatory strategies and organizational operations. The position coordinates regulatory communications, responses, and compliance documentation for interactions with health authorities. It also collaborates with cross-functional teams to strengthen regulatory governance, documentation control, and compliance monitoring, supporting timely approvals and sustainable regulatory alignment across markets. Essential Functions: Lead and review dossier compilation & publishing for complex submissions Oversee DMF compilation & review process and submission strategies Direct eCTD & electronic submissions across regions Manage post-submission management and health authority responses Ensure robust document version control & governance Monitor regulatory intelligence and assess strategic impact Drive regulatory & supplement reporting and lifecycle updates Coordinate regulatory & health authority management engagements Ensure inspection readiness for DMF and audit preparedness Apply risk identification & mitigation in regulatory planning Ensure sustained regulatory compliance across product lifecycle Lead quality & audit readiness initiatives Additional Responsibilities: Qualifications Education: B. Pharm B. Pharm - Required M. Pharm M. Pharm - Preferred Experience: 8 years or more in 8 - 10 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/7887
Apply URL	https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7887
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 05:31:01Z
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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  "last_changed_at": "2026-06-02T11:26:12.785Z",
  "active_status": "active"
}

Parsed Structured

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}

Extensions

{}

Native Structured

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