Christiane Niederlaender

With more than 12 years of regulatory agency experience in biological medicines, Christiane supports chemistry, manufacturing, and controls (CMC) development plans and regulatory strategies for the EU and the FDA.  

Her experience is vast, spanning all types of regulatory submissions and agency interactions as well as advising on strategic considerations for product development. She has expertise in all classes of biological products, but her focus and passion are cell and gene therapies and related products, including genetically modified cells, viral vectors, RNA products and novel vaccines, including vectored vaccines.  

As an ex-regulator, she was a senior quality assessor and latterly manager of the Biologicals Unit at MHRA. She also served as the UK member on the Committee for Advanced Therapies (CAT) at the EMA.  

Education

She holds a PhD in Molecular Developmental Neurobiology from King’s College, London and has worked as a Postdoctoral Fellow at the Institute of Cancer Research, London. She is also a qualified barrister.