Karl Enters

Karl Enters, PhD, is a senior global regulatory strategist and former Chief Regulatory & Quality Officer with more than 25 years of experience guiding early-stage life science companies through complex regulatory transitions. His work includes first-in-human programs, novel mechanisms, indication expansion, and global regulatory strategy for innovative therapeutics and combination products.

Karl combines scientific depth with direct FDA regulatory negotiation experience, particularly in central nervous system and dependence-related therapeutics. Earlier in his career, he directed regulatory strategy for reduced-harm nicotine and cessation therapies, working with FDA and NIH collaborators on clinical evaluation frameworks for dependence-modifying products, including approaches focused on behavioral endpoints, exposure reduction, and demonstration of clinical benefit.

Over the past decade, Karl has led or overseen four FDA IND programs with corresponding EU clinical trial applications, three NDAs, multiple global marketing applications, and several 505(b)(2) drug and drug-device combination product programs. His experience also includes expedited development strategies, including an RMAT-designated biologic program, as well as Pre-IND, Type B, and broader regulatory strategy interactions with FDA review divisions.

Before joining consulting, Karl held executive and senior leadership roles including Chief Quality & Regulatory Officer at Zig Therapeutics, Vice President of Regulatory Affairs at GENETWORx, and Senior Regulatory Consultant at Axogen.

He has worked directly with FDA, EMA, MHRA, Health Canada, PMDA, and other global health authorities, and has led cross-functional development teams across North America, Europe, and Asia. As a regulatory and quality leader, Karl has partnered with executive teams and boards to align regulatory strategy with financing milestones, organizational growth, and commercialization planning.

Karl earned his PhD in Neurobehavioral Teratology from Binghamton University.