Regulatory Affairs Consultant

Undine Schachtschabel has over fifteen years of experience in all phases of clinical development, marketing authorization of small-molecule drugs and biologics, and corresponding international regulatory strategies.  Trained at a Max-Planck-Institute in Germany, she has in-depth experience in advanced research, innovator product development and post-licensing efforts across different therapeutic areas including immunology/oncology, infectious diseases, cardiovascular diseases, and endocrinology.  She has developed regulatory strategies for the US, Europe, and emerging markets, prepared CTD dossiers for INDs and MAAs and provided critical assessments for approval-quality key documents, advanced therapy medicinal products (ATMPs), pediatric investigation plans (PIPs/PSPs), and joint product licensing and registrations across US-American and European markets. She also supported post-authorization and license maintenance activities in due course.  Undine has liaised and successfully negotiated with US- and European Agencies, managed Scientific Advice-/Agency meetings, and worked within US and European corporate matrix teams as the regulatory point of contact for biotechnology- and pharmaceutical companies.