Amneal is hiring for the position of Senior Officer, Regulatory Operations (eCTD Publishing) in Ahmedabad, Gujarat. The vacancy is a full-time opportunity within the Regulatory Affairs category and is based at the company’s location near Shapath-V, Ahmedabad.
The role focuses on electronic Common Technical Document (eCTD) publishing and regulatory submissions, particularly for USFDA-regulated applications. It may be relevant to B.Pharm professionals with experience in regulatory operations, eCTD publishing, regulatory documentation and pharmaceutical submissions.
Amneal Recruitment 2026 – Job Highlights
| Job Detail | Information |
|---|---|
| Company Name | Amneal |
| Job Title | Senior Officer, Regulatory Operations (eCTD Publishing) |
| Job ID | 8889 |
| Job Category | Regulatory Affairs |
| Job Location | Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015 |
| Qualification | B.Pharm |
| Preferred Qualification | M.Pharm |
| Experience | 1–4 years; 1 year or more specified |
| Employment Type | Full time |
| Application Deadline | September 30, 2026 |
About Amneal
Amneal is a pharmaceutical company with operations that include regulatory and pharmaceutical development activities. The available vacancy is part of its Regulatory Affairs function and focuses specifically on eCTD publishing and regulatory submission operations.
Job Description
The Senior Officer, Regulatory Operations (eCTD Publishing) will support the preparation, publishing, validation and submission of regulatory dossiers in eCTD format.
The position involves working with submission documents across regulatory modules, ensuring correct document placement and metadata, performing technical validations and coordinating with teams such as Regulatory, CMC, Clinical, Nonclinical and Labeling.
Senior Officer, Regulatory Operations (eCTD Publishing)
The role is primarily focused on maintaining high-quality eCTD sequences for submissions such as ANDAs, NDAs, amendments and supplements. The candidate will also support USFDA ESG submissions, lifecycle management, technical troubleshooting and regulatory correspondence activities.
Strong attention to detail is important because the position involves checking document structure, metadata, hyperlinks, bookmarks, file naming, sequence continuity and validation results.
Eligibility / Educational Qualification
The vacancy specifies the following educational requirements:
- B.Pharm – Required
- M.Pharm – Preferred
The job information indicates an experience range of 1–4 years, with 1 year or more specified under the experience requirement.
Candidates should have relevant exposure to regulatory operations or eCTD publishing activities.
Skills and Qualifications
The position requires skills related to:
- eCTD publishing and regulatory submissions.
- USFDA regulatory requirements.
- ICH regulatory guidelines.
- Regulatory filings and documentation.
- Regulatory compliance.
- Regulatory reporting.
- Documentation and record control.
- Data governance and compliance.
- Regulatory intelligence.
- Analytical thinking and problem-solving.
- Cross-functional collaboration.
- Effective communication.
- Technical review of regulatory submission documents.
- Understanding of submission lifecycle management.
- Attention to document structure, metadata and version control.
Knowledge of ICH M4, M8 and FDA eCTD guidance is specifically mentioned in the job description.
Key Responsibilities
The Senior Officer may be responsible for:
- Preparing, compiling and publishing eCTD sequences for ANDAs, NDAs, amendments and supplements.
- Ensuring submissions comply with USFDA eCTD technical specifications and applicable ICH guidelines.
- Managing US-regional Module 1 requirements.
- Checking the placement and metadata of cover letters, Form 356h, labeling, SPL, REMS, correspondence and ESG submission properties.
- Reviewing Module 2 summaries and Module 3 CMC/Quality content for accuracy and consistency.
- Ensuring appropriate document granularity, file naming and placement within the eCTD structure.
- Applying PDF publishing standards such as pagination, bookmarks, hyperlinks and table of contents.
- Checking document headers, footers, legibility, OCR and accessibility requirements.
- Conducting pre-publication checks and eCTD validation.
- Resolving technical errors and warnings before submission finalization.
- Troubleshooting file, link, path, STF and schema-related issues.
- Managing eCTD lifecycle operations, including new, replace, append and delete actions.
- Maintaining leaf tracking, sequence continuity, audit trails and version control.
- Defining and maintaining accurate submission metadata.
- Coordinating with Regulatory, CMC, Nonclinical, Clinical and Labeling teams to obtain submission-ready documents.
- Preparing and submitting regulatory sequences through FDA ESG.
- Monitoring ACK1, ACK2 and ACK3 messages and supporting resolution of transmission issues.
- Tracking updates to USFDA eCTD technical guidance, Module 1 specifications and validation requirements.
- Supporting requirements related to the transition toward eCTD v4.0.
- Preparing Study Tagging Files (STFs) where applicable.
- Validating the structure and relationships of applicable clinical, nonclinical and quality study sections.
- Establishing timelines and critical paths for submission sequence readiness.
- Escalating publishing risks and supporting appropriate mitigation.
- Managing regulatory correspondence within the applicable eCTD structure.
- Supporting meeting packages and minutes in eCTD format.
- Investigating recurring validation problems through root-cause analysis.
- Supporting corrective and preventive actions (CAPA) aimed at improving submission quality.
Work Location and Shift Details
The position is based at:
Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015, India
The job is listed as full time.
Specific working hours or shift timings have not been provided in the available job information.
Salary / CTC
Salary details have not been specified in the available job information. Candidates should refer to the official Amneal careers portal or employer communication for compensation details.
Selection Process
The available job posting does not specify the exact selection process, interview rounds or assessment stages. Candidates should follow the recruitment instructions provided by Amneal during the application process.
Benefits / Career Opportunities
The available vacancy information does not specify particular salary benefits, bonuses, insurance, transportation or other employment perks for this position.
The role provides professional exposure to regulatory operations, eCTD publishing, USFDA submissions, regulatory documentation and cross-functional pharmaceutical submission activities.
How to Apply
Interested and eligible candidates can apply through the official Amneal India careers portal for the Senior Officer, Regulatory Operations (eCTD Publishing) position.
The Job Identification number is 8889. Candidates should review the qualification and experience requirements before submitting their application.
The listed application deadline is September 30, 2026, at 12:00 AM.
Important Details Before Applying
- Company: Amneal
- Position: Senior Officer, Regulatory Operations (eCTD Publishing)
- Job Category: Regulatory Affairs
- Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat
- Qualification: B.Pharm
- Preferred Qualification: M.Pharm
- Experience: 1–4 years; 1 year or more specified
- Job Type: Full time
- Job ID: 8889
- Application Deadline: September 30, 2026
Important Note
Job availability, eligibility requirements, application deadlines and recruitment conditions may change. Candidates should verify the latest information on Amneal’s official careers website before applying. Applicants should also carefully review the specific requirements for the eCTD publishing role and ensure that the information provided in their application is accurate.
FAQs
Who can apply for the Amneal Senior Officer Regulatory Operations job?
Candidates with a B.Pharm qualification and relevant experience can be considered for the position. M.Pharm is listed as a preferred qualification.
What qualification is required for this Amneal job?
A B.Pharm degree is required, while M.Pharm is preferred according to the vacancy information.
How much experience is required?
The job posting indicates an experience range of 1–4 years, with at least 1 year or more specified under the experience requirement.
What does the eCTD Publishing role involve?
The position involves preparing and publishing eCTD sequences, performing technical validations, managing submission metadata and lifecycle operations, supporting FDA ESG submissions and coordinating regulatory documentation.
Where is the Amneal Regulatory Operations job located?
The position is based at Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015.
What is the application deadline?
The listed deadline is September 30, 2026, at 12:00 AM. Candidates should verify the current vacancy status on the official Amneal careers portal before applying.