Regulatory Affairs Assistant

il y a 1 jour

Leuven, Belgique PSI CRO Temps plein

Company Description
We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 1,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

**Job Description**:
This is a fantastic opportunity to join our international Regulatory Affairs team. You will support regulatory aspects of clinical research projects, streamline communication, maintain electronic systems and managing documents for studies in Belgium and the Netherlands.

This position will be based at our Leuven office, however there is the possibility to work up to three days a week from home.
**You will**:

- Act as a point of contact for clinical project teams and support services on regulatory matters
- Prepare draft regulatory/ethics submission dossiers
- Be responsible for document management such as filing, processing, translations and quality control
- Update and maintain (automated) tracking systems, working files, and schedules
- Organise meetings, prepare agendas and minutes

**Qualifications**:

- Ideally, you will have a College/University degree or an equivalent combination of education, training & experience
- Life Science degree is a plus
- Prior experience in an administrative role is advantageous, along with experience in, or knowledge of the Clinical Research industry
- Fully proficient in Dutch and English, and French is beneficial
The ability to plan, multitask and work in a dynamic team environment
- Excellent communication and collaboration skills

Additional Information
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. We have a generous benefits package here at PSI as we understand the importance of giving back to our employees. Our benefits are focused on providing you with the support to excel both at work, and in your personal life

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