Dr. Sibylle Kaiser is heading the Group Corporate Regulatory Affairs Development at Biotest AG. She is a Regulatory Affairs professional with more than 12 years of pharmaceutical industry experience. In her current position she is involved in planning and implementation of regulatory strategies for drug development programs and product enhancement plans. She has expert knowledge of regulatory requirements (CMC, preclinical, clinical) for development and life cycle management of antibodies, antibody-drug-conjugates, and plasma-derived products. Therapeutic area experience includes immunodeficiency and haematologic diseases, oncology and prevention of virologic infection. Prior to joining Biotest she was working for Abbott GmbH and Aventis Pharma. She holds a PhD in cancer research, a diploma in Molecular Biology and a Master Degree in Drug Regulatory Affairs (MDRA).