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
Tel.: +49 (0) 228-22787821