Ulrike Behr

Ulrike Behr

Ulrike Behr

Senior Director, Clinical Trial Regulatory Services

Ulrike joined Parexel in 1996 in a Medical Affairs function and transitioned to Regulatory Affairs in 1998. Since then she has built her broad global regulatory expertise in Clinical Trials and Marketing Authorization for various products.

Work Experience

Ulrike is an appointed member of the European Scientific and Regulatory Committee at ACRO (Association of Clinical Research Organizations). Her responsibility includes the strategic, financial and operational management of Clinical Trial Applications to regulatory authorities worldwide, as well as the review, adaptation and translation of clinical study labels of investigational medicinal products and regulatory consulting associated with interventional clinical trials, non-interventional and Market Access programs. She also provides internal and external regulatory consultancy and strategy to various project teams. She is a strategic leader and provides oversight for the regulatory aspects for several global Parexel Partnerships. She has coordinated in close cooperation with the regulatory client teams the setup and successful implementation of the partnership environment to the global Parexel team. Ulrike is also experienced in Marketing Authorization Application, Renewal and Variation procedures and dossier generation for pharmaceutical products to be filed in the European Union and in Central and Eastern European countries in liaison with the competent regulatory authorities and bodies. She has Line Management responsibilities for the Berlin CTRS group as well as for the Teams in India, Turkey, Russia and the Ukraine.

Education

Ulrike holds a degree in Chemistry and an additional degree in Environmental Sciences from FriedrichSchiller-University, Jena, Germany

We are always available for a conversation.

*