What I’ve learnt from preparing Regulatory Strategies – before you begin…

So you’ve been asked to prepare a Regulatory Strategy… good for you! You’ve been given an opportunity to contribute at a higher level and demonstrate how you bridge your technical expertise with your organisation’s drivers. Though consider yourself warned – even if you are up for challenges, preparing a Regulatory Strategy may both frustrate and excite you in equal measure.  And that’s not all – there’ll likely be an energetic exchange of views following close examination of your strategy.

Having prepared countless Regulatory Strategies, I’ve learned how important it is to consider a few things before putting finger to keypad. Whether your focus is a niche market or global saturation; a medicine, medical device, novel therapeutic or a line-extension… a few early considerations can be invaluable.

In my experience, overuse of technical jargon, misaligned assumptions and missed opportunities to challenge assumptions are all too-common findings in Regulatory Strategies. Embarking on a detailed investigation of Regulatory pathways when a short verbal overview at the next project meeting suffices, is another one. As is confusing strategy (the why and the how behind the proposed approach) with a plan (detailed milestones).

Your objective in preparing a Regulatory Strategy is to provide strategic advice to your organisation,  so remember to keep in check your personal views about the ask and to shift focus away from what you know to what your audience wants to know.

Here are a few more tips to get you going…

Five questions to consider prior to preparing a regulatory strategy

  • How does the particular initiative fulfil the organisational strategy?
  • What deliverable is expected from you, and when is it due?
  • Who is the audience?
  • What assumptions or constraints are relevant, and which might be challenged?
  • What is the risk appetite for this particular initiative?