Regulatory Affairs Specialist - Publishing

The Regulatory Affairs Specialist - Publishing is responsible for leading the electronic publishing process and providing end-to-end submission support to the North America regulatory team. This includes formatting, compiling, and publishing submission-ready documents into compliant eCTD sequences for INDs, DMFs, BLAs, NDAs, ANDAs, and other regulatory applications. The Specialist will serve as the primary publisher for the US and Canadian Regulatory Affairs teams, collaborating closely with authors and project teams to ensure timely, high-quality submissions to health authorities.

Work Schedule: Monday - Friday 8am - 4:30pm

• Format MS Word and Adobe PDF files to be submission-ready according to department standards and health authority requirements
• Create hyperlinks and bookmarks within and across documents/sections
• Compile, validate, and publish eCTD sequences, ensuring accurate metadata and structure
• Coordinate publishing timelines with RA team and other stakeholders to meet project deadlines
• Maintain records and correspondence in the regulatory tracking system
• Provide guidance and training to authors on document formatting, submission standards, and lifecycle updates
• Identify and implement process improvements to enhance publishing efficiency and quality
• Troubleshoot and resolve technical publishing issues, escalating when necessary
• Stay informed on updates to FDA, ICH, and eCTD guidance
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor's degree in relevant field of study.
• A minimum of 1-3 years of hands-on experience with publishing, and compiling eCTD submissions using publishing tools (e.g., Lorenz DocuBridge, Extedo, or similar). Experience with electronic submission publishing software and applications
• Knowledge of FDA, ICH, and Health Canada submission requirements preferred. Excellent communication, interpersonal, time management, and organizational skills.
• Close attention to detail required.
• Ability to work autonomously under limited direction on multiple projects simultaneously
• Demonstrates a working knowledge of publishing technologies/software.
• All employees must read, write and speak fluent English

Working Conditions:

• This position will work in typical office conditions with extensive time using computer equipment.
• Close attention to detail required.
• Willingness to work in a team-based environment.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.