Kathrin brings more than 25 years of experience across pharmaceutical development, quality, and regulatory affairs, with deep expertise in nonclinical strategy and regulatory execution across small molecules, biologics, and cell and gene therapies. She is a trusted regulatory leader known for guiding complex programs from early development through IND readiness with clarity and precision. When organizations are navigating critical earlystage decisions, they rely on Kathrin for her ability to align nonclinical strategy with broader development and regulatory goals. Her experience spans INDenabling programs, regulatory submissions, and health authority interactions, including pre-IND, INTERACT, and other FDA engagements. She has led and contributed to multiple successful IND submissions across a range of therapeutic modalities. At Syner-G, Kathrin partners with biotech and pharmaceutical companies to develop integrated regulatory strategies that ensure nonclinical, CMC, and clinical components are aligned from the outset. Her approach emphasizes clear, concise regulatory messaging and well-structured development plans that reduce risk and support efficient progression into clinical trials. Kathrin is highly experienced in regulatory documentation and strategy development, including nonclinical study design, gap assessments, regulatory roadmaps, and briefing packages. She brings a strong foundation in cGMP, GLP, and GCP, along with hands-on experience supporting manufacturing, quality systems, and regulatory compliance across development programs.
Prior to joining Syner-G, Kathrin held senior leadership roles in regulatory and scientific affairs, where she led cross-functional teams, supported global development programs, and advised sponsors on regulatory strategy and execution. Her experience spans both consulting and industry roles, giving her a practical perspective on advancing programs in dynamic and resource-constrained environments. Kathrin holds a PhD in Biochemistry from the University of Nevada, Reno, an MBA from the Rady School of Management at the University of California, San Diego, and a Bachelor of Science in Biochemistry from the University of California, Davis. She maintains Regulatory Affairs Certification (RAC) in Drugs.
