:

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 of Microsoft Office and Adobe PDF
- Hands on experience on eCTD compilation software such as PharmaReady/eCTDXpress/ Veeva etc.
- Hands on experience over any RIMS tool.
- Knowledge of eCTD format of Dossier
- Graduate from any Stream

Additional notes:

- Role is expected to work in all shifts.

📌 Executive (India)
🏢 Rubicon Research
📍 India