Purpose

eCTD Publishing and RIMS management

Position / Job Title

Executive - Publishing

Department

Regulatory Affairs

Reporting To

Assistant Manager - Publishing

Location:

Thane

Years Of Experience

Between 3-6 years of regulatory publishing experience

Dosage Form

ANY

Job Responsibilities / Deliverables

Manage the publishing of submission sequences for planned regulatory submissions in accordance with global health authority requirements.
Schedule and track submissions within the Regulatory Information Management System (RIMS) to ensure timely execution and compliance.
Maintain and administer RIMS, including submission lifecycle management, archival activities, and data integrity.
Utilize and manage RIMS templates to support productive and standardized submission processes.
Coordinate software patch updates for regulatory publishing, RIMS and compilation tools, ensuring timely implementation and system compliance.
Prepare high-quality electronic submissions using eCTD publishing software and industry best practices.




Perform comprehensive PDF quality checks, including legibility verification, bookmarking, page scaling, page sizing, OCR validation, and internal/external hyperlinking.
Compile, validate, and submit compliant eCTD dossiers for major regulatory regions, including the United States, European Union, UK, Canada, Australia, and other Rest of World (ROW) markets.
Execute technical validation of submissions using various industry-standard validation tools to ensure regulatory compliance and submission quality.
Collaborate closely with Regulatory – CMC teams to ensure submission readiness and adherence to project timelines.
Apply thorough knowledge of ICH eCTD guidelines, regional regulatory requirements, and electronic submission standards throughout the submission lifecycle.
Support continuous process improvements and contribute to the enhancement of regulatory publishing workflows and systems.

Qualifications & Pre-Requisites

Basic understanding

📌 Executive (Thane)
🏢 Rubicon Research
📍 Thane