Regulatory Affairs Publisher

• Submission Publishing: Prepare, format, and publish regulatory submissions (e.g., IND, NDA, MAA, variations, amendments) in electronic Common Technical Document (eCTD) and other required formats.

• Quality Control: Perform quality checks on submission components to ensure accuracy, completeness, and compliance with regulatory guidelines and technical requirements.

• Document Management: Manage and maintain submission-ready documents using document management systems and publishing tools.

• Collaboration: Work closely with regulatory affairs, medical writing, and project management teams to coordinate submission timelines and requirements.

• Regulatory Compliance: Stay current with evolving global regulatory requirements and ensure all submissions adhere to the latest standards (e.g., FDA, EMA, Health Canada).

• Issue Resolution: Troubleshoot and resolve technical issues related to document formatting, submission compilation, and electronic publishing.

• Process Improvement: Contribute to the development and optimization of publishing processes, templates, and best practices.

• Bachelor’s degree in Life Sciences, Information Technology, or a related field.

• Proven experience in regulatory publishing within the life sciences industry.

• Proficiency with electronic submission publishing tools (e.g., Lorenz DocuBridge, Extedo eCTDmanager, Veeva Vault RIM).

• Strong understanding of eCTD, NeeS, and other global submission formats and requirements.

• Excellent attention to detail and organizational skills.

• Ability to manage multiple projects and deadlines simultaneously.

• Strong communication and teamwork skills.

• Familiarity with document management systems and regulatory submission processes.

Quantabase Technologies