Dealing with the FDA
Developers have equally high expectations for their regulatory affairs recruits. It used to be that a good regulatory affairs person just had to understand the FDA's rules. Now, in a world with biosimilars and increased focus on drug safety, the FDA itself doesn't even know the rules. "You need strategic-thinking heads of regulatory affairs who can work with the FDA in a professional way to develop a collaborative relationship with agency heads," says Kleinman. Achieving that kind of relationship takes a tremendous amount of strategic thinking, regulatory knowledge and people skills.
Murphy recommends that the people most suited for regulatory affairs work at a small biotech be comfortable operating in the gray area. "In a small company you need a problem solver, someone who can handle all the moving parts." Working on a new program in the regulatory pathway may not always be as clear as management would like. That's because the political climate at the FDA rocks back and forth between safety and quick approval of new drugs, explains Kleinman, causing many companies to feel as though they're trying to hit a moving target when it comes to meeting the agency's demands. "The industry is searching for regulatory people who understand the market factors facing the FDA and who can be proactive and savvy of the FDA's mood," Kleinman observes.
Just like small biotech, Big Pharma has certain sought-after candidates on its "must-hire" list. In the last several years, Kleinman says his firm has been contacted by Big Pharma to fill brand new positions that didn't exist before for one of two reasons. First, a mega-merger may have created a new therapeutic area or position that suddenly becomes the prime focus of a combined company. Also, pharma looks for assistance when it's entering a totally new scientific or medical area. Ten years ago, he says, his company was asked for assistance in filling a number of translational medicine positions. Five years ago, Big Pharmas were looking for experts in personalized medicine. The latest demand is for biosimilar experts. Calls are also coming in for executives with experience in rare diseases, orphan diseases and emerging markets.
The pharma industry has been rocked by massive layoffs in the last several years. But for those with clinical or regulatory expertise in sought-after therapeutic areas, there's an opportunity to play a pivotal roll at up-and-coming biotech companies.
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