Dr. Pahala Simamora serves as the Director of the Division of Product Quality Assessment IX (DPQA IX), within the Office of Product Quality Assessment II (OPQA II), OPQ/CDER at the FDA. His division oversees the quality assessment of regulatory submissions under both the PDUFA and GDUFA programs, including those involving radiopharmaceutical products. Dr. Simamora has played an important role in several key FDA initiatives. These include the Abbreviated New Drug Application (ANDA) Integrated Quality Assessment process, which streamlines the review of generic drug submissions; the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME), which explores innovative regulatory approaches for mobile and advanced manufacturing technologies; and the Knowledge Aided and Structured Assessment (KASA) initiative, which advances structured quality assessments of generic drug applications. Before joining the FDA in 2010, Dr. Simamora brought with him 14 years of pharmaceutical industry experience, with deep expertise in formulation development, process development, and manufacturing scale-up – a foundation that continues to inform his regulatory and scientific leadership at the Agency.