Christiane Niederlaender

Christiane has spent 18 years in biological medicines, tissue, cell and gene therapy regulation, 12 years of this in governmental regulatory agencies, including over 9 years at the UK medicines regulator MHRA.

Christiane has experience in CMC and regulatory strategy for all types of biological products, with a particular focus on gene and cell therapies, novel biotherapeutics, biosimilars and vectored vaccines. While at MHRA, she was the principal quality/CMC assessor for 10 centralized MAAs, including two full dossier applications for ATMPs as sole UK quality assessor (including CAR-T, cells).

Christiane joined Parexel in January 2021 as Vice President Technical for CMC and now works with developers to accelerate the journey of advanced therapies into the clinic and to market. Since joining Parexel, Christiane has done a substantial amount of work within the US system and has experience of EU, UK and US CMC requirements.