Junior Regulatory Publisher eCTD Submissions

Why This Role Matters

The Junior Regulatory Publisher plays an essential role in ensuring accurate compilation, publishing, and technical quality control of regulatory submissions. In the pharmaceutical and clinical research industry, timely and compliant submission of dossiers to Health Authorities is critical for product approvals and lifecycle management.
This role supports the preparation of high-quality electronic and paper-based submissions, ensuring adherence to global regulatory standards such as ICH and GCP guidelines. By maintaining document integrity, hyperlinking accuracy, and submission structure compliance, the position directly contributes to regulatory success and organizational credibility.
At IQVIA, regulatory publishing professionals support global pharmaceutical clients by enabling efficient, compliant, and technology-driven submission processes.

Job Description

The Junior Regulatory Publisher is responsible for supporting the compilation, publishing, and technical validation of regulatory submission documents. The role involves assembling dossiers in formats such as paper, NeeS, and eCTD, performing quality checks, and ensuring submissions meet Health Authority requirements.
The candidate will assist in bookmarking, hyperlinking, and generating tables of contents while ensuring adherence to applicable regulatory standards. This position requires attention to detail, strong organizational skills, and the ability to manage multiple tasks under deadlines within a structured regulatory environment.

Key Features of the Role:

• Position: Junior Regulatory Publisher
• Industry: Clinical Research / Regulatory Submissions
• Qualification: Bachelor’s Degree in Life Sciences
• Focus Area: eCTD and NeeS publishing
• Exposure to ICH and GCP guidelines
• Interaction with internal and limited external stakeholders
• Entry-level opportunity in regulatory publishing

Responsibilities

• Support compilation, publishing, and technical quality control of regulatory submissions
• Handle collection of submission components and assembly of dossiers
• Prepare and publish submissions in paper and electronic formats (NeeS, eCTD)
• Perform bookmarking, hyperlinking, and creation of tables of contents as per Health Authority guidelines
• Assist with collection of Clinical Study Report (CSR) appendices as per ICH guidelines
• Coordinate with internal stakeholders and support senior staff
• Manage day-to-day workload for assigned tasks
• Ensure compliance with company SOPs
• Participate in implementation of new SOPs and process updates
• Stay updated with regulatory publishing trends and industry developments

Required Qualifications

Candidates should demonstrate foundational knowledge of regulatory publishing and strong documentation skills.

Educational Requirements:

• Bachelor’s Degree in Life Science-related discipline (Mandatory)
• Preferred understanding of Regulatory Affairs and Publishing

Experience and Skills:

• Basic knowledge of Good Clinical Practice (GCP) and ICH guidelines or willingness to learn
• Strong verbal and written communication skills
• Excellent organizational and time management skills
• Proficiency in Microsoft Office and web-based applications
• High attention to detail and accuracy
• Ability to follow instructions and work independently
• Strong multi-tasking and deadline management skills
• Self-motivated, flexible, and proactive learning attitude

Salary Insights

Compensation will align with entry-level regulatory publishing roles within the CRO and pharmaceutical industry. Salary may vary depending on prior exposure to regulatory submissions, eCTD tools, and publishing software.

Company Overview

IQVIA is a global leader in clinical research services, healthcare analytics, and regulatory support solutions. The company partners with pharmaceutical and biotechnology organizations to accelerate drug development and ensure regulatory compliance worldwide. With strong technological capabilities and global expertise, IQVIA provides structured career pathways in regulatory operations and publishing.

FAQs

Q1. Is prior regulatory publishing experience mandatory?
No, basic knowledge is sufficient, and training will be provided.

Q2. What submission formats will I work on?
NeeS, eCTD, and paper-based submissions.

Q3. Is knowledge of ICH guidelines required?
Basic knowledge is preferred, but willingness to learn is acceptable.

Q4. Does the role involve client interaction?
Primarily internal interaction, with limited external communication under supervision.

Q5. Is this a technical or writing role?
It is a technical publishing and document management role within regulatory operations.

Application Tip

• Highlight any exposure to eCTD or regulatory documentation
• Mention understanding of GCP and ICH guidelines
• Emphasize strong MS Office skills
• Demonstrate attention to detail and organizational ability
• Showcase ability to handle multiple deadlines