Website:
rubicon.co.in
Job details:
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 efficient 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.
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