John Spoden

John Spoden has a significant amount of experience in regulatory affairs, particularly in the areas of CMC (Chemistry, Manufacturing, and Controls) and pharmaceuticals. John has held various leadership roles in companies such as Encoded Therapeutics Inc., Lundbeck, Alder Biopharmaceuticals Inc., Omeros Corporation, Dendreon, Spectrum Pharmaceuticals, Inc., Leiner Health Products, TEVA Pharmaceuticals USA, Biogen Idec, and Allergan, Incorporated.

Their most recent position was as the Vice President of Regulatory Affairs - CMC at Encoded Therapeutics Inc, where they currently work. Prior to that, they served as the Senior Director of Regulatory Affairs CMC at Lundbeck. John also held the position of Senior Director of Regulatory Affairs - CMC at Alder Biopharmaceuticals Inc. and the Director of Regulatory Affairs - CMC at Omeros Corporation.

Before that, they served as the Director of Regulatory Affairs CMC at Dendreon and the Senior Director of Regulatory Affairs at Spectrum Pharmaceuticals, Inc. John also held the position of Senior Director of Regulatory Affairs at Leiner Health Products, where they focused on oral prescription, over-the-counter drugs, and dietary supplements.

John Spoden's earlier roles include Associate Director to Director of Regulatory Affairs at TEVA Pharmaceuticals USA, where they led a team in the preparation, submission, and approval process of NDAs and ANDAs. John also worked as the Manager - CMC, Regulatory Affairs at Biogen Idec, responsible for defining regulatory strategies during product development and commercial manufacturing.

Their career began as a Manager of Regulatory Affairs at Allergan, Incorporated, where they managed CMC regulatory maintenance activities for BOTOX.

Throughout their career, John Spoden has demonstrated expertise in regulatory strategy development, submission preparation, compliance, and management of regulatory activities for various drug products.

John Spoden attended Northern Illinois University from 1981 to 1985, where they obtained a Bachelor of Science (B.S.) degree in Biology/Biological Sciences, General. John also earned a Bachelor of Sciences degree in Biology during the same period.