Regulatory Manager (m/f/d) – Regulatory Affairs in Clinical Trials in Bremen

We are looking for a dynamic full time Regulatory Affairs Manager or Assistant(office based) who wants to join a young and motivated group of Regulatory Experts in our headquarter in Bremen to strengthen our team, and who is open to taking responsibility for projects and fellow team members alike. 

All regulatory tasks within clinical trials are going to be part of your responsibility – from initial consultation regarding study submission, to providing input into managing the regulatory/ethics submissions documentation for drug and medical device trials in Europe. In this context of gaining the approvals for the conduct of clinical trials you will be involved in the collection and preparation of documents and the submission to regulatory authorities and ethics committees, where a delay might have impact on the entire study timelines. 

We are looking for a candidate who understands the importance of working against the time and has a strong service provider mentality. As the clinical study regulations change continuously, we need a person who like change management and is willing to learn continuously and is open for the following: 

• Communicates with regulatory authorities and ethics committees (with focus on submissions in Germany, Austria and Switzerland) 
• Taking responsibility for the communication with the Sponsor and your colleagues regarding all regulatory questions within a project
• Having the confidence to present regulatory concepts and requirements in front of clients and presenting key information and timelines in an understandable manner

  Your profile:

• Life science degree or any equivalent qualification and relevant work experience
• Experience in research or administrative work preferably in an international setting
• Professional experience in clinical research is a plus
• Solid knowledge of MS Office (Outlook, Excel, Word, and PowerPoint)
• Good communication skills, ability to work in a team, and organizational skills
• A district problem solving and hands-on mentality
• Attention to detail
• Familiar with regulatory requirements related to regulatory/ethics submissions dossiers
• Fluent in English, German language skills (at least B1, best B2 or higher) additional language are appreciated

  We offer:

• An independent, diverse and interesting area of responsibilities and an excellent working environment in the immediate vicinity of the University of Bremen
• A young and innovative corporate culture and management, with a clear path to personal development and the opportunity to take responsibility not only within projects, but also within the company
• Support and advancement in individual personal and professional development
• Flexible working hours

Your tasks:

• Coordinating a team involved in feasibility activities and reporting to the Project Management
• Preparation, review and management of regulatory submission dossiers
• Communication with competent authorities and ethics committees
• Creating and maintaining a database of collected information
• Supporting start-up activities of clinical trials
• Improving the process based on lessons learnt