Specialist, RA (fixed-term)

Updated: March 03, 2024 07:06 PM GMT

Full-time and Temp work Job in Seoul

50056702 - Specialist Reg Drug Project

Seoul, South Korea

RA specialist is responsible for getting product approval in Korea within a planned time-line and taking the most appropriate actions to keep the company business and products license compliant with government regulations and company procedures including Good Regulatory Practice (GRP).

Product registration & maintenance
• Develop the regulatory strategy/plan for the earliest launch of new products on best conditions (indication, forms, minimum documents requirements etc) in Korea by sourcing necessary documents from HQ’s worldwide regulatory function.
• Implement/manage products registration procedures required by Korean pharmaceutical regulation to achieve the earliest market entry.
• Harmonize Korean products labels and promptly notice to GRA about local impositions for the labelling from the MFDS to avoid any local issue. Update the safety information in line with the CDS and other reference countries’.
• Product lifecycle maintenance: Keep product license to be compliant with... More Detail