Director of Quality Assurance & Regulatory Affairs
Mr. Brooke Yakatan joined IRISYS in 2014. His responsibilities at IRISYS include the overseeing and maintaining of GMP compliance in both small- and large-scale manufacturing campaigns ranging from Phase 1 and Phase 2 to commercial products. Mr. Yakatan also coordinates the filing of annual reports for NDA/ANDA submissions and facility annual product reviews.
Prior to his current appointment at IRISYS, Mr. Yakatan held Quality Assurance and Regulatory positions at Noven Pharmaceuticals. He received Gold Star recognition for his valuable contributions to the company.
Mr. Yakatan was awarded a Master of Business Administration degree with distinction from Keller Graduate School of Management, a Bachelor of Science degree from Coleman University, and a Bachelor of Arts degree from the University of Florida. He has also completed specialized certificate programs in Quality Assurance, Regulatory Affairs and Biotechnology Manufacturing from the University of California, San Diego.