Skaidrit Kramer

Background

About Skaidrit Kramer

I help drive ideas to approval by combining deep scientific understanding with strategic regulatory evaluation and global development expertise.With 27 years of experience in Regulatory Affairs, I work as Senior Expert Global Regulatory Evaluation & Strategy, focusing on the regulatory assessment of development and in‑licensing opportunities and on shaping viable global regulatory pathways from early concept through market approval. I have worked on products for oncological, autoimmune and rare diseases.In addition to my industry role, I actively contribute to regulatory policy through the Pharmaceutical Industry Association (BPI) and through engagement in expert networks. In these settings, I support collaborative discussions and contribute to shaping regulatory perspectives.I previously held senior leadership roles including Director Global Regulatory Affairs, Director Global Regulatory Operations, and Head of Drug Regulatory Affairs EU, with responsibility for regulatory strategy and execution across Europe and major international markets.