Pooyeh Ahmadi, Ph.D., PMP®

Senior CMC Regulatory/Certified Project Manager with more than 10 years of experience spanning various stages of pharmaceutical/radiopharmaceutical development and life cycle management, providing strategies in regulatory affairs, project management, and drug process development. Experienced in leading technology transfer from development into pre-clinical and clinical production (cGMP) with a broad range of experience in supporting regulatory affairs initiatives such as Corrective Actions and Preventative Actions (CAPAs) as well as handling deviations, authoring and reviewing CMC regulatory documents (IND/NDA, CTA, and responses to questions from Health Authorities), leading investigations, preparing product specifications, validation reports, and sterility/stability protocols. Strong working understanding of the theory and practical application of a wide range of common pharmaceutical laboratory instruments including but not limited to HPLC, GC, UV, ELIZA, qPCR, RTLC, Western Blot, Cell Harvester, Plate Reader, Scintillation Proximity Assay (SPA) and Wizard Detector Gamma Counter, Gamma spectrometry, Alpha spectrometry, Liquid Scintillation Counter (LSC) and wet chemistry techniques (i.e. TLC, Viscosity, pH-test, etc.).