Sandra Hennig
Vice-President, Head of Regulatory Affairs Bayer
Dr. Sandra Hennig is an RA CMC Strategist at Bayer, focusing on regulatory CMC strategies for targeted radionuclide therapies and diagnostic radiopharmaceuticals in clinical development. With 12 years’ experience, she brings recognised expertise in quality documentation, health authority interactions, and CMC challenges linked to short-lived radionuclides, targeting moiety manufacture and control, and decentralized radioactive drug product manufacture. As a subject matter expert, she works closely with CMC, quality, supply, nonclinical, clinical, regulatory functions, and external partners to translate TRT innovation into robust, phase-appropriate control and dossier strategies. Engaged in industry associations, she advocates pragmatic, science-driven regulatory approaches.
Seminars
- Understanding how evolving global regulatory expectations across manufacturing, comparability, isotope supply and control strategy are reshaping the development and commercialisation pathway for targeted radiopharmaceuticals
- Exploring where regulatory fragmentation continues to create challenges across multinational TRP programs and determining how industry leaders are building more globally aligned CMC strategies to reduce downstream delays
- Examining how leading developers are proactively approaching scalability, manufacturing readiness, and supply resilience earlier in development to strengthen long-term regulatory and commercial success
