Regulatory Consultant (Veeva RIM)

Overview

Regulatory Consultant role focused on regulatory submissions, content planning, and project coordination using Veeva RIM and electronic submission tooling.

What you'll do

• Create and maintain content plans within Veeva Vault RIM.
• Translate Smartsheet timelines into Microsoft Project and Veeva Vault RIM.
• Plan, manage, and track regulatory submissions.
• Support Vertex Global Submission Managers with project management activities.
• Help coordinate and communicate regulatory submissions to Vertex Publishing.
• Work with firm deadlines while adapting to changing requirements and priorities.

What you'll need

• 5+ years of Regulatory Affairs work experience focused on publishing and/or submissions (with B.S. or equivalent).
• 3+ years of Regulatory Affairs work experience focused on publishing and/or submissions (with M.S. or equivalent).
• Proficiency with Veeva Vault RIM and related submission/planning workflows.
• Proficiency in electronic submission tools and software including eCTD and regulatory information management systems.
• Experience/proficiency with project management tools including Smartsheet and Microsoft Project, and working with Excel/Office timeline tools.
• In-depth understanding of regulatory requirements and guidelines including FDA, EMA, and ICH.

Details

• Location: CAN-Remote.