Regulatory Affairs professionals with experience in eCTD publishing and regulatory submissions have an opportunity to apply for a Senior Officer, Regulatory Operations (eCTD Publishing) position in Ahmedabad, Gujarat.

The position focuses on preparing, compiling, validating, publishing, and managing electronic regulatory submissions for the USFDA. Candidates should have strong knowledge of ICH M4, ICH M8, FDA eCTD guidance, Module 1 requirements, regulatory publishing standards, and FDA Electronic Submissions Gateway (ESG).

A B.Pharm is required, while an M.Pharm is preferred. Candidates with approximately 1–4 years of relevant experience in Regulatory Affairs, Regulatory Operations, eCTD publishing, or related submission activities should review the requirements below.

Senior Officer Regulatory Operations Job Overview

Key Responsibilities

As a Senior Officer in Regulatory Operations and eCTD Publishing, the selected candidate will support end-to-end preparation and management of regulatory submissions, particularly for the USFDA.

Key responsibilities include:

• 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.
• Manage eCTD lifecycle operations such as new, replace, append, and delete while maintaining sequence continuity and version control.
• Maintain accurate sequence metadata, including submission type, sequence number, submission description, and related sequence references.
• Coordinate with Regulatory Affairs, CMC, Clinical, Nonclinical, and Labeling teams to obtain submission-ready documentation.
• Prepare and transmit submissions through the FDA Electronic Submissions Gateway (ESG).
• Monitor and interpret ACK1, ACK2, and ACK3 and coordinate resolution of transmission-related errors.
• Monitor changes to FDA eCTD technical specifications, validation rules, regional Module 1 requirements, and eCTD v4.0 transition requirements.
• Execute and validate Study Tagging Files (STFs) where applicable.
• Establish submission timelines and critical paths and escalate potential publishing risks with appropriate mitigation plans.
• Support health authority correspondence, meeting packages, responses, and minutes in the appropriate eCTD structure.
• Perform root-cause analysis of recurring validation failures and support CAPA activities to improve first-time-right submissions.

Qualification and Eligibility

Candidates applying for this eCTD Publishing Senior Officer job in Ahmedabad should meet the following educational requirements:

Required Qualification:
B.Pharm (Bachelor of Pharmacy)

Preferred Qualification:
M.Pharm (Master of Pharmacy)

The position specifically identifies B.Pharm as required and M.Pharm as preferred. Applicants should not assume other degrees are eligible unless confirmed by the hiring organization.

Experience Required

Candidates should have approximately 1–4 years of relevant professional experience.

Relevant experience may include work involving:

• Regulatory Operations
• Regulatory Affairs
• eCTD Publishing
• Regulatory Submissions
• USFDA Submissions
• ANDA/NDA Publishing
• Regulatory Documentation
• Submission Lifecycle Management

Practical experience with eCTD publishing and USFDA submission requirements would be particularly relevant to the responsibilities described for this position.

Required Skills

Successful candidates are expected to demonstrate competencies in:

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

Knowledge of FDA ESG submissions, eCTD lifecycle management, validation procedures, PDF publishing standards, STFs, and submission metadata will also be valuable.

Why Consider This Regulatory Operations Role?

This position provides exposure to technically demanding areas of pharmaceutical Regulatory Affairs, particularly electronic regulatory publishing and USFDA submissions.

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.

How to Apply

Application Link