Stacy Nelson, RAC
Stacy Nelson provides project management, regulatory, operational and business development expertise to clients with projects in the late discovery through registration phases of development. With more than 25 years’ experience, she began her career at Cato Research, Ltd, where she held positions of increasing responsibility, ranging from Project Manager to Director, Drug Development. She has been an independent consultant for more than 15 years, managing projects ranging from due diligence to FDA interactions for multiple biotechnology and pharmaceutical companies. She has experience in the initiation and management of multicenter clinical trials in the areas of cardiovascular, neurology, oncology and metabolic diseases. Stacy also has experience in post-marketing pharmacovigilance and CMC regulatory compliance and has managed the preparation and submission of multiple successful IND and NDAs. She is certified by the Regulatory Affairs Professional Society (RAPS).
Stacy earned her BS in Biology from the University of North Carolina in Chapel Hill and is RAC certified by the Regulatory Affairs Professional Society Certification Board.
Stacy earned her BS in Biology from the University of North Carolina in Chapel Hill and is RAC certified by the Regulatory Affairs Professional Society Certification Board.