Regulatory Affairs Assistant

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Join our international team and support regulatory aspects of clinical research projects, streamlining communication, maintaining electronic systems and managing documents.

Hybrid role in Ankara, Türkiye

You will:

• Be the point of contact for clinical project teams and support services on regulatory matters
• Prepare draft regulatory/ethics submission dossier
• Be responsible for document management such as filing, processing, translation, quality control 
• Update and maintain (automated) tracking systems, working files, and schedules
• Organize meetings, prepare agendas and minutes

Qualifications

• College/University degree or an equivalent combination of education, training & experience
• Life Science degree is a plus
• Administrative work experience, preferably in an international setting
• Prior experience in Clinical Research is a plus
• Full working proficiency in Turkish and English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication and collaboration skills