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How to survive tough Regulatory situations?

No matter if you are a C-suite executive, a regulatory expert with many years of experience in industry or a complete newbie, tough regulatory situations are going to happen and can impact your business considerably.

You will get tough questions from regulatory agencies, discover gaps in your regulatory strategy and many things will not go as initially planned. Tough situations might impact your organization’s strategy, will shape your regulatory career and, if managed properly, make your teams stronger.

Is there anything you can do to be adequately prepared when tough situations occur?

Rule No. 1 – Don’t panic

Let’s imagine you are looking at the response from a regulatory agency and it’s not what you were hoping to see. Take a deep breath, stop doing whatever you are doing and think. Make sure you understand the issue correctly. Think who should be informed about the issue and about the language you are going to use in your internal communication. Think who should be in a leading role for managing the situation. The last thing you need in this situation is a nerve wrecking chain of never-ending emails with your colleagues asking the same question: “What next?”

Rule No. 2 - Analyze the message

Try to focus on the facts rather than interpreting the feedback without a detailed analysis. However, don’t forget that your Regulatory Professional is the right person to decipher the message and “translate” the regulatory talk to you and your colleagues. What’s not being said in the written communication is equally important as what’s being said. If you are not a regulatory professional yourself, ask your Regulatory colleague to offer the opinion based on their experience. Is an urgent follow up with the agency needed?

Rule No. 3 – Coordinate properly

A key to surviving tough regulatory situations is to coordinate them properly. Are there any written company instructions or SOPs you should follow?

Good situational management approach:

  • Let your Regulatory team initiate and coordinate the subsequent team response (make sure this is clear to everyone)

  • More experienced people should be chosen to lead

  • Regulatory Team should first analyse the situation and clearly communicate direct requests, indirect requests and potential fall-back options

  • Based on this input your senior management should decide if there is any impact to your organization’s strategy

  • Your teams should support Regulatory colleagues in deciding who will work on what and agree on timelines

  • All team members should work on their deliverables

  • Regulatory Team consolidates and finalizes the approach, and communicates back to the regulatory agency (if needed)

Bad situational management approach:

  • Let everyone interpret the situation independently without a clear leadership (“silo thinking”)

  • Skip the Regulatory assessment as a first step in assessing the situation

  • Put a novice Regulatory people to manage the situation

  • Skip discussion meetings and let people communicate only through emails

  • Let your Regulatory team just sum up everyone’s positions and solely communicate back to the agency (without any coordination and consolidation)

You might find some or more of the above-presented actions of a bad approach far fetched (and I hope you do since this means you work in an organization that has learned to manage these situations) but my experience showed me that these situations could often occur.

Rule No. 4 – Cautious flexibility

Sometimes as a Regulatory expert you will receive a call or get a tough question from agency representatives or from a potential business partner during a face-to-face meeting.

In these situations, you should be able to think on your feet. Luckily, after years of training, this comes naturally to experienced colleagues. Good experienced people with a right attitude are a tremendous asset in similar stressful situations.

Aim to be well prepared and always try to predict the worst-case scenario beforehand. If the right answer doesn’t come to your mind right away or you have doubts in your response the best approach is to say “Thank you for your question/comment/request. We will get back to you as soon as possible with our feedback/answer/proposed course of action.” This approach worked for me in the toughest regulatory situations and will work also for every member of your team.

Rule No. 5 - Lessons learned

It is a wise approach to limit the management of a tough regulatory situation to a small group of people since it is much easier to coordinate the response in that case. Companies also tend to intuitively do this.

Since the discussion and resolution is managed by a small group of people it is advised to organize a Lessons Learned forum with a broader audience so other people can learn of the situation and how it was handled. Don’t let the knowledge get lost- document, file and share the knowledge with your colleagues. Your teams will be better prepared next time the similar regulatory situations occur and new ideas might pop-up.

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