Amneal Recruitment 2026 offers an opportunity for experienced pharmaceutical and regulatory affairs professionals to join the company as a Senior Executive – Clinical Affairs in Ahmedabad, Gujarat. The position is part of the Clinical Affairs function and involves providing operational and administrative support to global clinical trial teams working on New Chemical Entity (NCE) development programs.
The role focuses on clinical trial documentation, regulatory submissions, site and vendor coordination, study tracking and support for global clinical operations. The selected professional will also contribute to digital and AI/ML-enabled clinical trial activities, including data management workflows, trial dashboards and technology-supported clinical operations.
Candidates with a Bachelor’s degree in a Science field and at least 6 years of experience in Pharmaceutical or Regulatory Affairs, along with hands-on experience in FDA submissions, may be suitable for this opportunity.
Amneal Recruitment 2026 – Job Highlights
| Particulars | Details |
|---|---|
| Company | Amneal |
| Job Title | Senior Executive – Clinical Affairs |
| Job Identification | 8955 |
| Job Category | Clinical Affairs |
| Location | Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015 |
| Job Type | Full Time |
| Education | Bachelor’s Degree in Science |
| Preferred Qualification | Master’s Degree in Science |
| Experience | 6+ years in Pharmaceutical / Regulatory Affairs |
| Key Experience | FDA submission development |
| Work Area | Clinical Affairs / Clinical Operations |
| Salary / CTC | Not Specified |
About Amneal
Amneal is a pharmaceutical company that emphasizes innovation and a diverse and inclusive workplace. The company states that it provides equal employment opportunities and does not discriminate on legally protected grounds.
The vacancy is part of the Clinical Affairs function and involves supporting global clinical development programs, regulatory activities and cross-functional clinical operations.
Job Description
The Senior Executive – Clinical Affairs will provide operational and administrative support to global clinical trial teams involved in New Chemical Entity (NCE) development programs.
The position covers a broad range of clinical trial activities, including maintenance of essential trial documentation, regulatory submission support, study milestone tracking, communication with clinical sites and vendors, and coordination with global clinical operations teams.
The role also includes supporting the use of digital and AI/ML-enabled technologies in clinical trial operations, including data management workflows, tracking dashboards and other technology-supported processes.
The selected candidate will be expected to work in accordance with ICH-GCP, applicable regulatory requirements and internal SOPs.
Key Responsibilities
Clinical Trial Operations
- Provide operational and administrative support for global Phase 1–4 clinical trials involving NCE products.
- Track important study milestones and maintain relevant study trackers.
- Monitor documentation related to site initiation, patient recruitment and study close-out activities.
- Support coordination of clinical trial activities across global teams.
- Assist with clinical program reporting and management presentations.
- Maintain clinical project repositories and ensure appropriate version control.
Trial Master File and Documentation
- Maintain the Trial Master File (TMF) and support timely filing of essential clinical trial documents.
- Perform quality control activities related to clinical trial documentation.
- Support reconciliation of clinical trial documents, data listings and monitoring reports.
- Maintain accurate project documentation and associated records.
- Assist with preparation of monitoring plans, site manuals and training materials.
Protocol and Study Documentation
- Support protocol amendment activities.
- Assist with updates to the Investigator’s Brochure (IB).
- Support revisions to Informed Consent Forms (ICFs).
- Assist with preparation and maintenance of other study-related documentation.
Regulatory and Ethics Committee Support
- Assist with preparation and submission of regulatory and ethics committee packages.
- Support IND and CTA submissions, amendments and annual reporting activities.
- Maintain regulatory correspondence and submission trackers across different regions.
- Help ensure clinical documentation meets applicable regulatory requirements.
- Support activities related to FDA, EMA and CDSCO requirements.
Safety Reporting Support
- Coordinate documentation associated with clinical safety reporting activities.
- Support documentation workflows related to SUSARs, DSURs and PSURs.
- Assist in maintaining appropriate safety-related records and coordination with relevant stakeholders.
Site, CRO and Vendor Coordination
- Coordinate communication with global clinical sites, CROs, laboratories and other vendors.
- Support site selection documentation and feasibility questionnaires.
- Track documentation associated with site contracts.
- Assist with vendor oversight documentation.
- Support coordination involving laboratories, imaging vendors, ePRO/eCOA vendors, central laboratories and logistics providers.
Audit and Inspection Readiness
- Support audit and inspection readiness activities.
- Assist with TMF audit preparation.
- Support vendor audit-related documentation.
- Contribute to preparation for regulatory inspections.
- Help maintain documentation in accordance with applicable quality and compliance requirements.
Digital and AI/ML-Enabled Clinical Operations
- Collaborate with internal and external stakeholders on the implementation of AI/ML applications within the department.
- Support digital clinical trial activities and technology-enabled workflows.
- Assist with data management processes and clinical trial tracking dashboards.
- Contribute to the adoption of AI/ML-supported tools for clinical operations.
Team and Project Coordination
- Schedule meetings involving global clinical teams.
- Prepare meeting minutes and maintain action-item trackers.
- Coordinate information across internal and external stakeholders.
- Support preparation of clinical program reports and management presentations.
- Work effectively with teams operating across different functions and time zones.
Educational Qualification
Required Qualification
Candidates should have:
- A Bachelor’s Degree (BA/BS) in a Science field.
Preferred Qualification
- A Master’s Degree (MS/MA) in a Science field is preferred.
Experience Required
The vacancy specifies:
- 6 years or more of experience in Pharmaceutical or Regulatory Affairs.
- Hands-on experience in developing FDA submissions.
- Demonstrated knowledge of FDA requirements.
Candidates with relevant experience in clinical operations, regulatory affairs and global clinical trial support may be well aligned with the responsibilities of this role.
Technical Skills and Specialized Knowledge
Candidates should have knowledge or familiarity with:
- Clinical trial lifecycle and associated regulatory requirements.
- Trial Master File (TMF) systems.
- Clinical Trial Management Systems (CTMS).
- Electronic Data Capture (EDC) systems.
- Clinical document management platforms.
- Pharmacovigilance and safety reporting fundamentals.
- AI/ML concepts relevant to clinical research.
- Microsoft Office and clinical trial software tools.
- FDA regulatory requirements.
- Global clinical trial documentation and compliance processes.
Required Skills
The job listing identifies the following skills as important for the position:
- Detail-oriented approach.
- Forecasting.
- Good Clinical Practices (GCP).
- ICH Guidelines.
- Project planning.
- Regulatory requirements.
- Risk management.
- Professional writing.
- Strong documentation skills.
- Stakeholder coordination.
- Effective communication.
- Ability to work across global cross-functional teams and time zones.
Work Location and Job Schedule
The position is based at:
Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015, India
- Job Schedule: Full Time
- Job Category: Clinical Affairs
- Work Environment: Global and cross-functional clinical operations
- The vacancy information does not specify remote or hybrid work arrangements.
Salary / CTC
The salary or CTC for the Senior Executive – Clinical Affairs position has not been specified in the provided job information.
Candidates should refer to the official Amneal recruitment communication for details regarding compensation and other employment terms.
Selection Process
The detailed selection process has not been mentioned in the provided vacancy information.
Candidates should follow the company’s official recruitment process. The selection may assess relevant educational qualifications, pharmaceutical or regulatory affairs experience, FDA submission knowledge, clinical trial understanding, communication skills and other role-specific competencies.
How to Apply
Eligible candidates interested in the Amneal Senior Executive – Clinical Affairs position should apply through the company’s official recruitment process for Job Identification 8955.
Before submitting the application, candidates should:
- Review the educational and experience requirements.
- Ensure their resume clearly reflects relevant Pharmaceutical or Regulatory Affairs experience.
- Highlight hands-on experience with FDA submissions.
- Mention relevant clinical trial, regulatory and documentation experience.
- Include knowledge of GCP, ICH guidelines and applicable regulatory requirements.
- Submit accurate professional and educational information through the official application channel.
Important Details Before Applying
- Company: Amneal
- Position: Senior Executive – Clinical Affairs
- Job ID: 8955
- Job Category: Clinical Affairs
- Location: Ahmedabad, Gujarat
- Job Type: Full Time
- Required Degree: Bachelor’s Degree in Science
- Preferred Degree: Master’s Degree in Science
- Experience: 6 years or more in Pharmaceutical / Regulatory Affairs
- Regulatory Experience: Hands-on FDA submission development experience
- Specialized Knowledge: FDA requirements
- Clinical Knowledge: Clinical trial lifecycle, GCP and ICH guidelines
- Key Systems: TMF, CTMS, EDC and document management platforms
- Salary: Not specified
Important Note
Job requirements, vacancy status, application procedures and other employment conditions may change. Candidates should verify the latest information from the official Amneal recruitment source before applying.
FAQs – Amneal Senior Executive Clinical Affairs Recruitment 2026
1. What position is Amneal hiring for?
Amneal is hiring for the position of Senior Executive – Clinical Affairs.
2. What is the job identification number?
The Job Identification number is 8955.
3. Where is the Amneal Clinical Affairs job located?
The position is located at Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015.
4. What educational qualification is required?
A Bachelor’s Degree (BA/BS) in a Science field is required. A Master’s Degree in a Science field is preferred.
5. How much experience is required?
The vacancy requires 6 years or more of experience in Pharmaceutical or Regulatory Affairs.
6. Is FDA regulatory experience required?
Yes. The listing specifies hands-on regulatory experience developing FDA submissions and demonstrated knowledge of FDA requirements.
7. What clinical trial systems should candidates be familiar with?
The role mentions familiarity with TMF systems, CTMS, EDC and document management platforms.
8. Does the role involve global clinical trials?
Yes. The position provides operational and administrative support to global clinical trial teams involved in Phase 1–4 NCE development programs.
9. Does this position involve AI and machine learning?
Yes. The role includes supporting digital and AI/ML-enabled clinical trial activities, including data management workflows, tracking dashboards and technology-supported trial operations.
10. Is the job full time?
Yes. The vacancy is listed as a Full Time position.
11. Has Amneal specified the salary?
No specific salary or CTC has been provided in the vacancy details.
This version is structured for direct publication and keeps the distinction clear between the required qualification, preferred qualification, experience, technical skills and responsibilities.