Non-Clinical Regulatory Assessor | Biologe (m/w/d)

Paul-Ehrlich-Institut

Langen (Hessen), Hessen, Deutschland
Published Oct 10, 2025
Full-time
No information

Job Summary

This role seeks a highly analytical Non-Clinical Assessor to join the Paul-Ehrlich-Institut, a key federal scientific institution responsible for the regulation of vaccines and biomedical drugs in Germany and Europe. The successful candidate will primarily focus on evaluating the non-clinical aspects of applications for clinical trials and market authorizations, particularly within the specialized field of Hematology, Cell, and Gene Therapy. Day-to-day responsibilities include assessing new biological products across various development stages, providing scientific advice to developers and manufacturers, and contributing to the establishment of regulatory guidelines and standards for innovative therapies, such as genome-editing candidates. This position requires a Master's degree or comparable scientific qualification in Biosciences, preferably with a PhD, coupled with strong molecular/cell biology and/or virological knowledge. The role is challenging, impactful, and requires excellent organizational, analytical, and teamwork skills, offering a unique opportunity to shape the future availability of new medicines.

Required Skills

Education

Completed scientific university degree (Master or comparable) in Biosciences with a scientific PhD

Experience

  • Professional experience in assessing non-clinical aspects of drug applications (national and European level)
  • Experience in providing scientific advice to companies and scientists regarding drug development
  • Experience contributing to the development of regulatory guidelines and standards
  • Professional experience working with complex scientific contexts

Languages

English (Fluent)

Additional

  • Fixed-term employment for three years; Requires submission of a Declaration of Interests towards the EMA; Requires submission of a declaration according to § 77a AMG (German Medicines Act)