RA Specialist(Á¤±ÔÁ÷)/±Û·Î¹ú¿Ü±¹°èÁ¦¾àȸ»ç
±Û·Î¹ú¿Ü±¹°èÁ¦¾àȸ»ç RA Specialist ¸¦ 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
- 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
- Maintain high level of authorities' satisfaction through application of high professional standard in all contacts,
quick resolution of authorities' enquiries and provision of support.
- 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 :
- Pharmacist
- More than 3 years of experience in the regulatory - Good command of spoken and written English
´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