Sandra Lee Bihary Waltz

Senior Director of Regulatory Affairs, PRA Health Sciences


Don’t limit yourself to your academic degree, advises Waltz, who has a master’s in nursing but thought outside the hospital and is currently earning her doctorate in business at Wilmington University.

As the senior director of regulatory affairs at PRA Health Sciences, she helps pharmaceutical companies large and small (and some virtual) develop and get their drugs approved in the U.S. and worldwide.

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“Every prescription drug out there must have a clinical trial to support it,” she explains. “My colleagues and I help clients understand all the requirements.” Waltz has worked with drugs for everything from conjunctivitis to cancer. “Oncology drugs are my real love because of the immediate benefits they can have,” she says.

In a similar role at other companies during the past 30 years, she’s helped get pharmaceuticals passed for breast, prostate and ovarian cancers, among others. “Being able to develop a drug that improves people’s lives is tremendously fulfilling,” says Waltz, who credits her faith for the “moral compass” that steers her career.

As a contractor for the Department of Defense, Waltz also provides regulatory advice on medical countermeasures against bioterrorism threats like ebola, anthrax and chemical radiation. Crediting her own mentors—men and women—for her success, Waltz offers this advice to young women: “Find an older person who can help you navigate the challenges within your field. As the older generation, it’s our responsibility to help people who are younger and give them the tools to develop themselves—and the next generation.”

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