Ask a life sciences hiring manager which positions are giving them trouble, and regulatory affairs will often make the list. The issue isn’t that people aren’t interested in regulatory work. The bigger problem is finding someone with the right kind of experience for a specific product, company, and stage of development.
Regulatory affairs is one of those careers where experience builds slowly. Someone can understand FDA requirements and have a strong technical background, but that isn’t the same as having spent years working through submissions, responding to agency questions, supporting product changes, or helping a team prepare for the next stage of development. This distinction matters when a company needs someone who can walk in and handle the work with little training.
The challenge is that regulatory experience can get very specific very quickly. Someone may have a strong background in regulatory affairs but still not have the experience a particular company needs. A pharma company might be looking for experience in a certain therapeutic area, while a medical device company may need someone who has worked with a specific type of submission. Smaller biotech companies can have another challenge altogether, since they often need someone who is comfortable taking on a wider range of responsibilities. By the time all of those preferences are added together, the number of candidates who check every box can be pretty small.
Another issue is that regulatory experience doesn’t always transfer as neatly as employers would like. Ten years in regulatory affairs can mean very different things depending on the products someone has supported and the work they’ve actually handled. One person may have spent most of that time working with marketed products, while another has been heavily involved in clinical development. Someone else may have extensive U.S. experience, but limited involvement with international submissions. This puts hiring managers in a difficult position. They need enough experience to reduce the learning curve, but requiring an exact match in every area can eliminate people who are capable of doing the job. A candidate who hasn’t worked on the exact same product may still understand a similar regulatory pathway or have dealt with many of the same challenges.
The timing of regulatory hiring can make things even harder. Companies don’t always have the luxury of starting these searches months in advance. A new program moves forward, a submission approaches, the company receives feedback from regulators, or an experienced employee leaves. Suddenly, a position that wasn’t a priority a few months earlier needs to be filled quickly.
Experienced regulatory professionals aren’t necessarily searching job boards when that happens. Many are already working on important programs, preparing for major submissions, or simply comfortable where they are. Reaching them can require a different approach than posting a position and waiting for applications, particularly when the company needs someone with a very specific background.
This is also where it helps for hiring managers to reconsider what an ideal candidate really looks like. If someone hasn’t worked on the exact same product, does their experience still translate? Could experience with a similar regulatory pathway be enough? Is a certain number of years actually necessary, or is the company really trying to find evidence that the person has successfully handled certain situations before? Asking those questions can open up a search without lowering expectations for the position.
Hiring managers also need to be realistic about the interview process. A company can spend weeks finding someone with a specialized background and then lose that person during another several weeks of interviews and internal discussions. There is still a need to evaluate candidates carefully, especially for positions that carry significant responsibility, but delays that don’t add anything to the decision can become a problem when the candidate pool is already small.
The shortage of experienced regulatory professionals doesn’t have one simple solution because the experience itself takes time to develop. Companies can, however, be more deliberate about how they search for it. Knowing which experience is essential, where related experience can transfer, and what the company can realistically teach gives hiring teams more room to work with.
For Scientific Search, regulatory searches often come down to finding that balance. The strongest candidate isn’t always the person whose background matches every line of the job description. Sometimes it’s the person who has already dealt with the kinds of regulatory problems the company is about to face and has the experience to help the team work through them.
