Regulatory Affair Specialist - Bonn, Deutschland - monipol International

Beschreibung

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.