Zo maak jij het verschil
We are looking for a versatile regulatory and start-up leader with excellent interpersonal skills to support teams in managing (international) national clinical regulatory and EC submission and approval processes in clinical trials. The organisation works on various (international) projects and for different types of clients (e.g., pharmaceutical companies, biotech, etc.). As part of their dedicated Regulatory Team (5 FTE), you will report directly to the Regulatory Manager.
You will also act as a liaison between audit committees, regulators, local partners, suppliers and customers to ensure agreements are approved and supplementary information is provided in a timely manner as required. You will also prepare regulatory and EC submission and approval plans at the start of the project and create and maintain a database of up-to-date information on ongoing and completed research.
Furthermore, your tasks and responsibilities for this role will be to:
- Develop and maintain the organisation’s regulatory training courses for all relevant stakeholders;
- Provide input to proposals and bid defence for regulatory and ethical submission activities;
- Ensure the high quality of the clinical trial submission process by conducting quality control activities;
- Ensure that (local) activities are carried out by the agreed timetable, allocated budget and required quality standards;
- Identify and assess regulatory risks and related project issues and make recommendations to stakeholders;
- Ensuring that general and research-specific regulatory processes comply with (international) national laws and regulations;
- Acquire and maintain knowledge of (international) national clinical regulatory laws and requirements.
Wat jij mee brengt
The requirements for this role are:
- Higher level of education, preferable in pharmacy or life sciences;
- 5 years of experience in Clinical Trials;
- 2 or 3 years of regulatory/filing experience (preferably European and/or international filing);
- Extensive knowledge of the EU Clinical Trials Directive and related guidance documents as well as ICH guidelines and international submission rules and procedures;
- Need to understand medical device regulations;
- Sufficient oral and written knowledge of English, preferably Dutch;
- Adequate written and spoken knowledge of French is an advantage.
This organisation offers you an open culture, inspiring colleagues, and good working conditions in an innovative and dynamic environment. An environment where you can be creative, and proactive and a space that directly impacts the way they work.