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Æ÷Áö¼Ç : |
RA Specialist(Á¤±ÔÁ÷) |
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±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. |
°æ·Â¿ä°Ç : |
- Pharmacist
- More than 3 years of experience in the regulatory
- Good command of spoken and written English |
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ÀüÈ : |
02-2050-0299 |
Á¦Ãâ¼·ù : |
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ÀüÀÚ¿ìÆí : |
hs@mstone.co.kr |
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