Currently, Iraj Daizadeh, PhD, MBA, is the Vice President/Head of Global Regulatory Affairs (GRA) for the Specialty Business (Brands/Innovative Medicines/Biosimilars) at Sun Pharmaceuticals. His current work is to build a cross-discipline, worldwide regulatory and quality team suitable to support a mid-to-large pharmaceutical company portfolio comprised of a variety of inline (Leqselvi, Ilumya, Winlevi, Cequa, Odomzo, Yonza, Absorbica, Levulan, Xelpos) and pipeline small and large molecule assets across rheumatology, oncology, dermatology, gastrointestinal, ophthalmology, and internal medicines indications.Immediately prior to Sun, at Takeda, he was the VP/Head, GRA, Rare Diseases (Genetics, Immunology and Hematology), where his team successfully led two original global marketing applications to approval (Livtencity (NDA, CDER) and Adzynma (BLA, CBER)) and met various inline (Trintellix, Takhzyro, Vonvendi, Natpara, Advate, Adynovate) and pipeline milestones. He joined Takeda as VP/Head, GRA, Neuroscience and Global Regulatory Intelligence and Policy, focusing the company’s efforts on the COVID-19 crises and PDUFA VII legislation. Prior to joining Takeda, he was the Global Regulatory Portfolio Leader, Head, GRA, at Pfizer, progressing its neuroscience and internal medicine inline (Eliquis, Champix, Toviaz, Opioids) and pipeline portfolios. Since 2000, Iraj has driven medical product regulatory activities across rare and common diseases (e.g., immunology, hematology/oncology, cardiometabolic, infectious disease), modalities (cell and gene therapies, biologics, small molecules, digital, diagnostics, devices, combinations) and phases (discovery to lifecycle) at Sun Pharmaceuticals, Takeda, Pfizer, Novartis, Amgen, and Baxter/Baxalta.He received his PhD from the University of California at Davis, a postdoctoral fellowship at Harvard University, and an MBA (strategy) from the Judge Business School at the University of Cambridge (UK). He has authored approximately 40 peer-reviewed publications, many of which are related to the regulatory sciences. He also holds certificates in regulatory affairs (RAC) and project management (PMP).Skills: Clinical trial and marketing applications (IND/CTA/NDA/BLA/MAA/JNDA); global (e.g., US, EU, Japan, China, ROW) health authority interactions (asset and policy-level) and product defense strategies (e.g., advisory committees/oral hearings); orphan and expedited program designations (FTD/BTD/Prime/Sakigake); MLR/labeling/ad-promo; regulatory innovation
