Job Description 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.
Office-based in Seoul Your role: Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications 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 Qualifications College/University degree or an equivalent combination of education, training, and experience At least 3 to 5 years of prior experience with clinical trial submissions in Korea Full working proficiency in English and Korean Proficiency in MS Office applications Detail-oriented Ability to learn, plan and work in a dynamic team environment Communication, collaboration, and problem-solving skills Additional Information This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.
Free
Regulatory Officer, Korea South
Korea South, 서울, 서울,
게시됨 December 18, 2024