Home › Companies › Hcfa Fa Us2 Oraclecloud Com CX 5001 › Assistant Manager, Regulatory Affairs
Assistant Manager, Regulatory Affairs
Hcfa Fa Us2 Oraclecloud Com CX 5001 · Shapath, Ahmedabad, Gujarat, IN · 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 | - |
| Employment type | Full Time |
| Salary | - |
| Status | active |
| ATS provider | Oracle Recruiting Cloud / Fusion HCM |
| Posted / first seen | 2026-05-21 / 2026-05-31 |
| Changed / last seen | 2026-06-06 / 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 |
| 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
Qualification: M.Sc. Chemistry or M.Pharm
Experience : 8 -15 yrs
Scientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps. Preparation & review of ANDA/NDA Drug Substance Modules & related activities. Preparation of project status & updates for discussion in next level. Assessment of change controls & vendor notifications. Technical writing of deficiency responses, modules & other scientific regulatory documents, as required. Participation in project meetings, coordination with CFTs, good communication & coordination. Supporting Europe & Canada market due diligence projects for Drug substance part, as required. Knowledge of current regulatory guidelines is required. Experience of complex APIs will add value. Knowledge of using AI in routine work will add value.
Full job record
| Job ID | f8f2086f405a64a2d56ea6458fb0a96ff6cc77e1 |
| 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 | 8021 |
| Title | Assistant Manager, Regulatory Affairs |
| Normalized Title | — |
| Status | active |
| Active | yes |
| Location Text | Shapath, Ahmedabad, Gujarat, IN |
| Department | Regulatory Affairs |
| Team | — |
| Employment Type | full_time |
| Workplace Type | — |
| Remote Policy | — |
| Country | United States |
| Region | IN |
| City | Gujarat |
| Salary Raw | Description Qualification: M.Sc. Chemistry or M.Pharm Experience : 8 -15 yrs Scientific review of external API vendor’s DMFs in context of ANDA/NDA & resolving any gaps. Preparation & review of ANDA/NDA Drug Substance Modules & related activities. Preparation of project status & updates for discussion in next level. Assessment of change controls & vendor notifications. Technical writing of deficiency responses, modules & other scientific regulatory documents, as required. Participation in project meetings, coordination with CFTs, good communication & coordination. Supporting Europe & Canada market due diligence projects for Drug substance part, as required. Knowledge of current regulatory guidelines is required. Experience of complex APIs will add value. Knowledge of using AI in routine work will add value. |
| Salary Min | — |
| Salary Max | — |
| Salary Currency | — |
| Salary Period | — |
| Source URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/8021 |
| Apply URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/8021 |
| 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 | 2026-06-06 11:07:11Z |
| Inactive At | — |
| Source Posted At | 2026-05-21 05:27:03Z |
| 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 |
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