Regulatory Publishing Technical Consultant (Regulatory Systems)

Overview

Technical Consultant on the Regulatory Operations team, acting as subject matter expert for regulatory publishing systems, document management technologies, and electronic submission tools supporting global regulatory activities.

What you'll do

• Provide technical support for regulatory publishing and submission management systems.
• Troubleshoot issues related to eCTD publishing tools, document management systems, PDF creation, Microsoft Office applications, and desktop environments.
• Configure, install, test, validate, and maintain regulatory technology solutions.
• Support system validation activities, execute test scripts, and document results.
• Maintain compliance with regulatory submission standards, publishing guidelines, and industry best practices.
• Manage multiple priorities while ensuring high-quality deliverables and service levels.
• Partner with clients, regulatory teams, and software vendors to resolve technical challenges and deliver effective solutions.
• Act as a trusted advisor on publishing technologies and regulatory systems.
• Support project teams by sharing expertise and mentoring less experienced team members.
• Participate in client meetings and provide recommendations to improve efficiency and system utilization.
• Build strong relationships with internal and external stakeholders while ensuring client satisfaction.

What you'll need

• 3+ years of experience in Regulatory Operations, Regulatory Publishing, eCTD Submission Management, Regulatory Technology Support, or Regulatory Information Management (RIM).
• Experience supporting or using one or more of the following platforms: Veeva Vault RIM, Documentum, EXTEDO, Lorenz Calyx RIM, or similar regulatory publishing or document management systems.
• Strong understanding of eCTD submissions, regulatory publishing processes, global regulatory submission standards, and submission lifecycle management.
• Experience performing system troubleshooting, software testing, validation activities, and user support.
• Advanced proficiency with Microsoft Office Suite, Adobe Acrobat, and Windows operating systems.
• Fluent English communication skills, both written and verbal.
• Bachelor's degree in Life Sciences, Technology, Computer Science, Pharmacy, Regulatory Affairs, or a related field.

Nice to have

• Experience writing and executing validation protocols and test scripts.
• Experience working within a CRO, pharmaceutical, biotechnology, or regulatory technology environment.
• Prior client-facing or consulting experience.
• Experience mentoring team members or acting as a subject matter expert.

Details

• Location: Canada, British Columbia; remote.