Regulatory Affair Specialist
vor 2 Wochen
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:
Tasks
- 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.
**Requirements**:
- 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
**Benefits**:
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.
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