Regulatory Coordinator
Full course · Regulatory Submissions & Stakeholder Management
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Designs the comprehensive regulatory calendar as the RC's master operating document, defines its data architecture, populates it from real submission types, and evaluates platform trade-offs.
Course 1 introduced the idea that portfolio management requires a different kind of visibility than study-by-study tracking. You understood, conceptually, that an RC needs to see the full regulatory landscape at once. Module 1 of this course taught you to build the submission tracking system -- the per-submission record that logs every filing, every status change, every approval date for every study at your site.
This lesson builds the next layer. The regulatory calendar is not the tracking system. It is the operational view that sits on top of it.
Think of it this way. The tracking system answers the question: What is the status of this submission? The regulatory calendar answers a different question entirely: What does my next 90 days look like? The tracking system is a record. The calendar is a forecast. The tracking system tells you where you have been. The calendar tells you where you are going -- and, critically, where the collisions are hiding.
I have seen sites with impeccable tracking systems -- every submission logged, every approval date recorded, every status current -- that still miss continuing review deadlines because no one ever assembled those individual records into a forward-looking operational view. The data existed. The visibility did not. The calendar is what creates that visibility.
What you will learn3 objectives
By the end of this lesson, you will be able to:
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