Do you have the ability to show ownership ánd do you have excellent communicative skills and knowledge of regulatory legislation to join the driven Regulatory team in delivering high-level work? Then join Julius Clinical in managing global clinical drug trials that will have a major impact on medicine and in ensuring that data obtained from trials is of the highest quality.
We are looking for a multitalented Regulatory & Start-up Lead with excellent social skills to join the team in managing the (inter)national clinical regulatory and EC submission and approval process within a clinical trial. We work on a variety of (international) projects and for diverse types of customers (e.a. pharma companies, biotech etc.) As part of our driven Regulatory team (3 FTE), you will directly report to our Manager Regulatory.
Tasks and responsibilities
- Act as a liaison between the review committees, regulatory agencies, Local Partners, vendors and the client to ensure that protocols are approved, and that supplementary information is provided in a timely manner as requested;
- Create a regulatory and EC submission and approval plan at the start of a project;
- Create and maintain a database with up-to-date information on ongoing and completed trials;
- Develop and maintain a Julius Clinical regulatory training plan for all stakeholders involved;
- Provide input to proposals and bid defences on regulatory and ethics submissions activities;
- Ensure a high level of quality of the clinical trial submission processes by performing Quality Control activities;
- Ensure (local) activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards;
- Perform progress reporting to stakeholders;
- Identify and assess regulatory risks and related project issues and makes recommendations to stakeholders;
- Assure compliance of general and study-specific regulatory processes with (inter)national law and regulations;
- Gain and maintain knowledge of (inter)national clinical regulatory legislation and requirements.
- Higher level of education, preferable in pharmacy or life sciences;
- 5 years of experience in Clinical Trials;
- 2 or 3 years’ experience within the Regulatory work field / submissions (preferably with European and/or international submissions);
- Extensive knowledge of EU Clinical Trial Directive and respective guidance documents as well as ICH guidelines and international submission regulations and procedures;
- Knowledge of Medical Devices regulations is preferable;
- Adequate command of written and spoken English and preferably Dutch;
- Adequate command of written and spoken French is an advantage;
- Skills: communicative, stress resistant, overview, multitasking, leadership.
An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.
We are located in a beautiful monumental building, close to Slot Zeist and close to public transport e.g. busses and train station Driebergen-Zeist. In the current COVID situation, our employees work from home as much as possible. After COVID we intend to offer the option of working from home, working at the office or a combination of the two.