Regulatory Affair Specialist in regulatory affairs and clinical trials for our office in Germany

We are currently looking to recruit a Regulatory Affairs Specialist (RAS) with experience in clinical trials to join our German operations based in our Bonn office.

As a Regulatory Affairs Specialist, you will have at least two year of experience in the regulatory field of clinical trials and be responsible for the following:

  • Preparing ethics committee and regulatory submission packages according to relevant German regulatory requirements;
  • collecting and updating information on EC and regulatory requirements;
  • filling, tracking, preparing and maintaining trial documentation.

In carrying out these duties, you will be fostering close contact with sponsors and site investigators.

As a successful candidate, you will possess the following core competencies:

  • A minimum of two years of experience in the clinical trials regulatory field, with a good grasp of regulatory guidelines of clinical trials conduct in Germany
  • Excellent organizational skills and attention to details
  • Ability to work to tight deadlines and to prioritise workload in a dynamic and fast-moving environment
  • Excellent interpersonal skills and strong client service mentality
  • Self-motivated and proactive, with ability to work across multinational teams
  • Good oral and written communication skills in English
  • Demonstrable ability to analyse and evaluate complex information

We offer you an attractive remuneration package and the opportunity for personal and professional growth in an international environment. If you are a motivated self-starter, and working in a dynamic and growing research and medical consultancy appeals to you, we would like to hear from you.

Please send your application to the following address:

monipol International GmbH
Dr. Jaroslaw Stepien
Heilsbachstr 22-24
53123 Bonn
Tel.: +49 (0) 228-22787821