Karl Enters

Karl Enters has extensive experience in regulatory affairs and quality management across various industries. Karl is currently serving as the Vice President of Regulatory Affairs at GENETWORx, where they are responsible for all aspects of global regulatory affairs and regulatory quality. Karl is actively involved in regulatory filings, engagement with regulatory bodies, and developing regulatory programs to support the company's anticipated growth.

Prior to their current role, Karl worked as a Senior Director of Regulatory Affairs at NJOY, where they oversaw product analysis, manufacturing, and regulatory affairs. Karl also has experience as a self-employed consultant, providing regulatory affairs, quality, and product risk management services to medical device startups. During this time, they worked on a variety of projects involving biologics, respiratory disease therapies, inhalation dosimetry, and implantable combo drug/devices.

Karl has also held senior leadership positions at Altria, ERM: Environmental Resources Management, Celanese, and International Specialty Products. In these roles, they managed global product life cycle regulatory and safety programs, engaged cross-functional teams, and supported product development, due diligence, and acquisition activities.

Overall, Karl Enters has a strong background and expertise in regulatory affairs, quality management, and product risk management in the healthcare, chemical, and consumer goods industries.

Karl Enters holds a Master's and Doctoral degree in Neurobehavioral Teratology from Binghamton University. Prior to pursuing their advanced degrees, they completed their Bachelor of Science in Biology from Eastern University.