Drug development programs cost hundreds of millions of Dollars, if not two Billion Dollars. Given this huge spend, ensure that you have taken good advice.

Many regulatory professionals will laugh if I say, that in any company there are many regulatory experts. Everyone on the project team will have an idea of how the regulatory process should be conducted. To get their point across, they can go around the internal regulatory team by asking their colleagues in other companies for advice about their regulatory challenges. They will then bring back that advice and basically create havoc in the team..

How should regulatory experts be used?

There is a good way to bring an expert regulatory professional on board, and a bad way. The best way is to create a constructive process to identify and hire the expert. The last thing I would want is for the internal regulatory team to feel threatened by the expert that is being brought in.

Here are some suggestions for hiring regulatory experts

  1. Identify the challenges that need to be solved.
  2. Create a specific scope of work.
  3. Identify regulatory experts who have the experience needed.
  4. Ensure the expert selected will report into a senior executive level.
  5. Ensure the budget is commensurate with the challenge you need to solve.

Don’t ask a regulatory expert to report into a junior regulatory professional!

The reason for this should be obvious. A regulatory expert could earn more in an hour than the junior member of staff earns in a week. There are dynamics that need to be managed, and the expert should report into the CEO or the COO, not to a junior member of staff. This should make sense, but it never ceases to amaze me that this is often neglected. If you leave the hiring of your regulatory experts to your internal members of staff who are extremely junior, do not be surprised when your program is not a success.