Amneal Hiring For Regulatory Affairs

Amneal is hiring for the position of Executive, Regulatory Operations (eCTD Publishing) in Ahmedabad, Gujarat. The role focuses on electronic Common Technical Document (eCTD) publishing, regulatory submissions, USFDA compliance, submission validation, and lifecycle management for ANDAs, NDAs, amendments, and supplements.

Candidates with a B.Pharm qualification and 5–8 years of experience in regulatory operations and eCTD publishing can review the eligibility criteria and job responsibilities below.

Job Details

Position

Executive, Regulatory Operations (eCTD Publishing)

The selected candidate will be responsible for preparing, compiling, publishing, validating, and managing regulatory submission sequences in accordance with USFDA eCTD technical specifications and applicable ICH guidelines.

Key Responsibilities

• Prepare, compile, and publish eCTD sequences for ANDAs, NDAs, amendments, and supplements.
• Apply regulatory guidelines, including ICH M4, ICH M8, and USFDA eCTD guidance.
• Manage US regional Module 1 requirements, including cover letters, Form FDA 356h, labeling (SPL), REMS, correspondence, and ESG submission properties.
• Ensure accuracy and consistency across Module 2 summaries and Module 3 CMC/Quality documentation.
• Apply PDF publishing standards covering pagination, bookmarks, hyperlinks, tables of contents, headers, footers, OCR, legibility, and accessibility.
• Conduct pre-publication checks, resolve validation errors and warnings, and troubleshoot file paths, links, Study Tagging Files (STFs), and schema issues.
• Manage eCTD lifecycle operations, including new, replace, append, and delete activities, while maintaining sequence continuity, leaf tracking, audit trails, and version control.
• Maintain accurate sequence metadata, including submission type, sequence number, submission description, and related sequence references.
• Coordinate with Regulatory, CMC, Nonclinical/Clinical, and Labeling teams to ensure submission readiness and timely delivery.
• Submit regulatory sequences through the FDA Electronic Submissions Gateway (ESG), monitor ACK1, ACK2, and ACK3 acknowledgements, and resolve transmission errors.
• Monitor updates to USFDA eCTD technical guidance, regional Module 1 specifications, validation rules, and eCTD v4.0 transition requirements.
• Execute and validate STFs where applicable for quality, nonclinical, and clinical study sections.
• Establish submission timelines, identify risks, and coordinate mitigation measures.
• Manage health authority correspondence, responses, meeting packages, and minutes in the appropriate eCTD locations.
• Perform root-cause analysis of recurring validation failures and implement corrective and preventive actions (CAPA) to improve first-time-right submissions.

Eligibility and Qualifications

Candidates should meet the following requirements:

• Required education: Bachelor of Pharmacy (B.Pharm).
• Preferred education: Master of Pharmacy (M.Pharm).
• Experience: 5–8 years.

Relevant knowledge of eCTD publishing, regulatory submission requirements, USFDA technical specifications, and ICH guidelines is applicable to the responsibilities of this position.

Required Skills

Amneal is looking for candidates with the following skills:

• Analytical thinking and problem-solving
• Cross-functional collaboration
• Data governance and compliance
• Documentation and record control
• Effective communication
• Policy and regulatory intelligence
• Regulatory compliance
• Regulatory filings
• Regulatory reporting and documentation oversight
• Regulatory requirements

Application Details

Eligible candidates can apply for the Executive, Regulatory Operations (eCTD Publishing) position at Amneal in Ahmedabad.

• Application deadline: 30 November 2026
• Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015
• Job ID: 9427