Beating the Regulation Rush With Interim Executives

stack of medical regulations papers

stack of medical regulations papersJordan WarshafskyBy Jordan Warshafsky, Partner, Ashton Tweed

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My client, a biologics company, began preparing its Investigational New Drug (IND) application, but needed help from a regulatory professional who had biologics experience. At such a small company, the CEO didn’t feel the need to hire a permanent employee to help handle the IND submission. Instead, the company hired interim talent…


Regulations are constantly being added and amended in the life sciences industry. To make matters increasingly difficult, it’s tough for many businesses to bring on permanent regulatory professionals at certain stages of the product cycle. However, life science leaders know that regulatory affairs is not an area that can be skimped on. Fortunately, top regulatory executives are available on an interim basis –allowing you to pay for their skills only when you need them!


The opening case study is a perfect example of the interim talent solution. Having worked with many companies navigating through the regulatory process, I’ve seen firsthand how this solution is beneficial in more ways than one. Instead of just gaining the regulatory advice of a consultant, an interim executive is actually a member of your team and executes the work that needs to be completed. The biologics company mentioned above hired the top professional they needed without worrying about a time-consuming search process or adding a permanent salary to their budget.


This hiring strategy saves your company the time and money of hiring a permanent employee by giving you immediate, short-term access to highly qualified experts in areas like the following:

  • Regulatory guidance
  • Compliance
  • Quality assurance
  • Due diligence


This tactic also helps your company avoid costly regulatory mistakes down the road, by ensuring that you gain talent with the specific skills you require. Each company has unique needs, and interim talent enables you to hire a professional that best fits those needs. For example, your team may need a regulatory leader with these additional qualities:

  • Knowledge in your therapeutic area: vaccines, immunotherapy, rare/orphan diseases, etc.
  • Large and small company or start-up experience
  • FDA or EMA familiarity
  • Proficiency in all phases of the product pipeline
  • Solving complex regulatory issues


Be smart about your hiring strategy! Not all projects require long-term employees. Interim executives can help your company beat the regulation rush and lead other life science initiatives. Over half of my clients in the life sciences industry have hired interim talent to fulfill their hiring needs, so it’s wise to explore what interim talent can do for your business.


Find the missing piece to your regulatory team: Contact Ashton Tweed today.

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