Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 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
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 developing your professional career.
Office located in Seoul, South Korea
This position is offered as a one-year contract, with the possibility of renewal or conversion to a permanent role.
Your role:

• Develop submission strategies and plan study regulatory timelines
• Assess regulatory aspects of study feasibility, support PSI Business Development team in winning new studies for the region
• Track changes/amendments to legislation requirements related to clinical research and maintain the database of regulatory requirements
• 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

Qualifications

• College/University degree in Pharmacy, Medicine, Life Sciences, or an equivalent combination of education, training and experience
• Prior experience with clinical trial submissions to MFDS and ECs in South Korea
• 1 year or 2 years of industry experience in a similar role (a combination of startup & purely regulatory experience is possible) is a plus but not required for Regulatory Affairs Assistant
• 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