Christiane Niederlaender

Christiane has over 12 years of regulatory agency experience in biological medicines, specializing CMC development plans and regulatory strategies for the EU and FDA. Her experience is vast, spanning all types of regulatory submissions and agency interactions as well as advising on strategic considerations for product development. Her expertise lies in cell and gene therapies, viral vectors, RNA products, and novel vaccines, including vectored vaccines. As an ex-regulator, she served as a senior quality assessor and manager at the MHRA and was a member of the Committee for Advanced Therapies (CAT) at the EMA.