"I have extensive experience with regulatory assessment of medicinal products from early development to post-authorisation. I am currently the Global Regulatory Leader for both projects within late-stage and early development. I have previously been the principal assessor or internal/external peer-reviewer for several marketing authorisation applications, variation applications, post-authorisation commitments, and confidential scientific advices. I am highly skilled in writing concise and critical assessments in addition to preparing regulatory development strategies on which upper management can base executive decisions. My product portfolio comprises a wide variety of medicinal products including small chemical molecules, biopharmaceuticals (e.g., recombinant peptides, monoclonal antibodies [mAbs] incl. bispecific and conjugated mAbs, fusion proteins, etc.) and advanced therapies (i.e., gene and cell therapy medicinal products). I have assessed and provided scientific and regulatory advice for a huge range of different medicinal products intended for the treatment of various therapeutic indications ranging from orphan to common diseases. As a leader, I’m able to motivate and support the team in challenging situations while leading individuals in a constructive and empathetic manner. I believe that the best foundation for high-performance teams is a high degree of transparency and knowledge-sharing. Importantly, I strive towards continuous development of my team members to ensure both personal and professional/scientific growth. As a person, I’m outgoing, motivated, honest, enthusiastic, proactive, organised, and independent. I have excellent communication and presentation skills. Finally but not least I have excellent stakeholder management skills with a great understanding of both the established and the informal internal decision processes within a large pharmaceutical company."  

The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm Intestinal transporters for endogenic and pharmaceutical organic anions: the challenges of deriving in-vitro kinetic parameters for the prediction of clinically relevant drug-drug interactions