Regulatory Operations Position at Amneal | Apply Now
A rare chance has emerged for Regulatory Affairs professionals with experience in eCTD publishing and regulatory submissions to apply for the Senior Officer, Regulatory Operations (eCTD Publishing) position at Amneal in Ahmedabad, Gujarat. This Amneal Regulatory Operations Job focuses on preparing, compiling, validating, publishing, and managing electronic regulatory submissions for the USFDA.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company dedicated to providing high-quality, affordable medicines. Furthermore, the organization operates in the pharmaceutical sector, focusing on developing and manufacturing generic and specialty pharmaceuticals. With a commitment to innovation and quality, Amneal aims to enhance patient access to essential medications worldwide.
- Company: Amneal Pharmaceuticals
- Position: Senior Officer, Regulatory Operations (eCTD Publishing)
- Job Category: Regulatory Affairs
- Job ID: 8889
- Qualification: B.Pharm required; M.Pharm preferred
- Experience: 1–4 years
- Location: Ahmedabad, Gujarat, India
- Job Type: Full Time
- Application Deadline: 30 September 2026
- Application Mode: Online
- Focus Area: eCTD Publishing & Regulatory Submissions
Amneal Regulatory Operations Job Description
In this Amneal Regulatory Operations Job, the Senior Officer in Regulatory Operations and eCTD Publishing will support end-to-end preparation and management of regulatory submissions, particularly for the USFDA. This includes ensuring compliance with regulatory requirements and maintaining high standards in eCTD publishing.
Key Responsibilities
- Prepare, compile, and publish high-quality eCTD sequences for ANDAs, NDAs, amendments, and supplements according to USFDA technical specifications and applicable ICH guidelines.
- Maintain working knowledge of regulatory requirements including ICH M4, ICH M8, FDA eCTD guidance, and regional submission requirements.
- Manage US regional Module 1 requirements, including cover letters, FDA Form 356h, SPL labeling, REMS documentation, correspondence, and ESG submission properties.
- Review Module 2 summaries and Module 3 CMC/Quality documentation for consistency, granularity, file naming, and correct placement within the eCTD backbone.
- Perform PDF publishing activities covering pagination, bookmarks, hyperlinks, tables of contents, headers, footers, OCR, accessibility, and document legibility.
- Conduct comprehensive pre-publishing checks and technical validations before submission.
- Identify and resolve technical errors involving links, files, paths, schemas, and Study Tagging Files.
- Coordinate with Regulatory Affairs, CMC, Clinical, Nonclinical, and Labeling teams to obtain submission-ready documentation.
Eligibility Criteria
Required Qualification: B.Pharm (Bachelor of Pharmacy)
Preferred Qualification: M.Pharm (Master of Pharmacy)
However, applicants should not assume other degrees are eligible unless confirmed by the hiring organization.
Required Skills
- eCTD publishing
- Regulatory filings
- USFDA regulatory requirements
- Regulatory documentation
- Regulatory compliance
- Data governance and compliance
- Document and record control
- Analytical thinking and problem-solving
Why Consider This Regulatory Operations Role?
This Amneal Regulatory Operations Job provides exposure to technically demanding areas of pharmaceutical Regulatory Affairs, particularly electronic regulatory publishing and USFDA submissions. Moreover, the role can help experienced Regulatory Affairs professionals strengthen expertise across eCTD sequence publishing, ANDA/NDA submissions, FDA ESG transmission, Module 1 requirements, lifecycle management, technical validation, CMC documentation, and evolving eCTD standards.
Conclusion
The Senior Officer, Regulatory Operations (eCTD Publishing) position at Amneal offers an excellent opportunity for qualified candidates to advance their careers in Regulatory Affairs. Therefore, interested individuals are encouraged to apply for this Amneal regulatory affairs role before the deadline of 30 September 2026.
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