Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.
Hybrid role in Ankara, Türkiye
You will:
- Prepare independently clinical trial submission dossiers for Regulatory and Ethics Authorities
- Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
- Review translations of essential documents subject to clinical trial submission
- Track the regulatory project documentation flow
- Review documents to greenlight IP release to sites
- Manage safety reporting to authorities.
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests.
- College/University degree
- Minimum 1 year of prior industry experience
- Full working proficiency in English and Turkish
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
