RA Specialist/±Û·Î¹ú¿Ü±¹°èÁ¦¾àȸ»ç
±Û·Î¹ú¿Ü±¹°èÁ¦¾àȸ»ç¿¡¼ Regulatory Affairs Specialist(1³â °è¾àÁ÷)¸¦ ã°í °è½Ê´Ï´Ù.
Accountabilities :
• 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.
• Product QA
- Package compliance : Secure the package compliance in line with the local regulation and company compliance. Quality Control: Give advice to the QC lab based on regulatory knowledge and lead the technical transfer.
- Quality complaint: Receive any complaint with regard to quality and handle the complaints with help of HQ in line with company¡¯s SOP
• Relationship with customers(internal & external)
- Maintain high level of authorities' satisfaction through application of high professional standard in all contacts, quick resolution of authorities' enquiries and provision of support.
• Intelligence Gathering
- Get any information relating to changes in the relevant regulatory regulations and health authorities and report to RA manager on any expected impact on our business.
Qualifications :
• Bachelor's Degree in pharmacy, life science or healthcare
• More than 1~3 years of experience in the regulatory
• Good command of spoken and written English
• Experience of working on cross-functional teams
• Knowledge of the drug development process department
´ã´çÀÚ : (ÁÖ)¸¶ÀϽºÅæ¼Ä¡ (www.mstone.co.kr) ¿øÇö¼÷»ó¹« ¿¬¶ôó : 02-2050-0299, 010-8911-5018 À̸ÞÀÏ : hs@mstone.co.kr Áö¿ø½Ã Á¦Ãâ¼·ù : ±¹¿µ¹®À̷¼ °¨»çµå¸®°í, ±Ã±ÝÇϽŠ»çÇ×ÀÌ ÀÖÀ¸½Ã¸é ¾ðÁ¦¶óµµ ¿¬¶ôÁֽñ⠹ٶø´Ï´Ù.
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003