Regulatory Affairs Specialist

Summarized Purpose: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions:
• Having good understanding of local regulations about IND applications and clinical trial conduct in Korea
• About 2-year experience in performing and managing local RA submissions (including direct communications with MFDS) and related activities including KPTA/KMDIA applications for clinical trials in Korea
• Good communication skills in Korean and English (both verbal and written)
• Global CRO experience is preferred. Local CRO experience only will be fine, but the candidate should be able to prepare local RA submission dossiers based on global packs with translation