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HomeCompaniesHcfa Fa Us2 Oraclecloud Com CX 5001Deputy 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

FieldValue
CompanyHcfa Fa Us2 Oraclecloud Com CX 5001
TitleDeputy Manager, Regulatory Affairs
Normalized title-
Department / teamRegulatory Affairs
LocationGujarat, IN, United States
Work model-
Employment typeFull Time
Salary-
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-05-04 / 2026-05-31
Changed / last seen2026-05-31 / 2026-06-06

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City jobsActive postings in Gujarat.Open
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Linked records

CompanyHcfa Fa Us2 Oraclecloud Com CX 5001
Source55674fbb-0c45-4fea-a514-ebaecaf9c870
ATS providerOracle 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 ID4f8f2de9d1b30f9259cf0d0b6cbb35472503e279
Org ID822a1eaf-b950-4323-90f0-79f735f12603
Source ID55674fbb-0c45-4fea-a514-ebaecaf9c870
Board ID55674fbb-0c45-4fea-a514-ebaecaf9c870
Provideroracle_hcm
Provider Job Key7089
TitleDeputy Manager, Regulatory Affairs
Normalized Title
Statusactive
Activeyes
Location TextShapath, Ahmedabad, Gujarat, IN
DepartmentRegulatory Affairs
Team
Employment Typefull_time
Workplace Type
Remote Policy
CountryUnited States
RegionIN
CityGujarat
Salary RawDescription 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 URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7089
Apply URLhttps://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/7089
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 At2026-05-31 18:02:43Z
Inactive At
Source Posted At2026-05-04 05:56:59Z
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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  "active_status": "active"
}
Parsed Structured
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Extensions
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Native Structured
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