WONJA
Course catalogue
Regulatory affairs

Regulatory Affairs Strategy

Regulatory strategy across a development programme, including agency interactions and labelling implications.

Level
Advanced
Length
10 hours
Lessons
12
Format
Self-paced

What you will be able to do

  • Build a regulatory strategy for a programme
  • Prepare for an agency meeting
  • Weigh accelerated and orphan routes
  • Connect strategy to study design

Course content

4 sections · 12 lessons · 10h total

Requirements

  • Familiarity with trial phases and study documents
  • Helpful, not required: experience with a submission or ethics package

Who this is for

  • Regulatory affairs and start-up staff
  • Coordinators who own ethics and submission packages
  • Professionals moving toward regulatory roles

Description

Regulatory strategy across a development programme, including agency interactions and labelling implications.

Written for experienced professionals who own the outcome. You work through 4 sections built around the tasks the role actually asks for, each with a short worked example and a checkpoint so you can tell whether the material has landed.

This sits in Regulatory affairs: Submissions, ethics and regulatory strategy. When you are ready to show the capability rather than describe it, the next step is Leadership tier, regulatory affairs route.

Where it leads

Leadership tier, regulatory affairs route. Completing a course builds capability. It does not by itself create Passport evidence: demonstrated work in Wonja Labs does.

See how Labs turns work into evidence

Common questions

Is this course assessed?
No. Checkpoints are for your own confidence. Assessed, reviewed work happens in Wonja Labs casebooks.
Does finishing this course create Passport evidence?
No. Courses build capability. Passport evidence comes from demonstrated work that is scored and reviewed in Wonja Labs.
Can I buy this on its own?
Yes. It is available as a single course, and it is also included in the Wonja Academy subscription alongside every other course and Labs access.
How long do I have to complete it?
It is self-paced with no deadline. Most people spread the material over two to three weeks alongside work.

More in Regulatory affairs

Regulatory Submissions and Ethics

IND, CTA, IRB and ethics committee submissions: what goes in, what delays approval and how to track it.

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