Home › Companies › Hcfa Fa Us2 Oraclecloud Com CX 5001 › Deputy Manager, Regulatory Affairs
Deputy 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 | Deputy 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 | 2026-05-04 / 2026-05-31 |
| Changed / last seen | 2026-05-31 / 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
Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
Draft and finalize controlled correspondences on complex issues.
Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
Review API and FP in-vitro characterization/sameness reports.
DMF review for complex APIs as per the workflow.
To collaborate and work closely with cross functional teams.
To meet the management expectations w.r.t timelines and quality.
To work closely within the team and provide training to new members on new regulatory requirements for Complex products.
Qualifications
Suitably qualified individuals with strong Scientific and Regulatory background.
Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years.
End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
Experienced in drafting controlled correspondences, Meeting packages etc.
Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
Solution orientated, strong sense of ownership and accountability.
Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way.
Company
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Full job record
| Job ID | 4f8f2de9d1b30f9259cf0d0b6cbb35472503e279 |
| 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 | 7089 |
| Title | Deputy 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 Prepare, Review and Finalize Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market. Draft and finalize controlled correspondences on complex issues. Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products. Review API and FP in-vitro characterization/sameness reports. DMF review for complex APIs as per the workflow. To collaborate and work closely with cross functional teams. To meet the management expectations w.r.t timelines and quality. To work closely within the team and provide training to new members on new regulatory requirements for Complex products. Qualifications Suitably qualified individuals with strong Scientific and Regulatory background. Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics. Experienced (minimum 8-10 years) in Regulatory Affairs with Injectable dosage form and overall experience 12+ years. End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc. Experienced in drafting controlled correspondences, Meeting packages etc. Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects. Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set. Solution orientated, strong sense of ownership and accountability. Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way. Company Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. |
| Salary Min | — |
| Salary Max | — |
| Salary Currency | — |
| Salary Period | — |
| Source URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7089 |
| Apply URL | https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7089 |
| 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 | 2026-05-31 18:02:43Z |
| Inactive At | — |
| Source Posted At | 2026-05-04 05:56:59Z |
| 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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