Sr.RA Specialist &RA Specialist/¹Ì±¹°èÁ¦¾àȸ»ç
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Sr. RA Specialist´Â °úÀå±ÞÀ̸ç, RA Specialist´Â ´ë¸®±ÞÀÔ´Ï´Ù.
ReportingÀº Regulatory & Scientific Affairs Director¿¡°Ô ÇϽʴϴÙ.
Primary Objective :To assist with the preparation of regulatory submissions of company products in order to obtain necessary regulatory approvals, to provide advice on regulatory matters to companypersonnel.
CORE JOB RESPONSIBILITIES:- Manage registration of new/line extension products, variations to marketed products to
ensure regulatory approvals are achieved in accordance with Company objectives.- Ensure Regulatory Compliance- Coordinate responses to deficiency letters and other requests for data in agreed timelines- Maintain contact with governmental officials of MFDS (former KFDA), and related health authorities to
facilitate evaluation processes.- Liaise with operations department and others to maintain product changes and ensure these comply
with regulations.- Review labeling, product information and promotional materials for compliance with relevant regulations
and codes.- Provide support for marketing plans and launch teams- Maintain good knowledge of the relevant Regulations & Code. - Prepare safety update reports, certified product details and import permits- Regulatory Intelligence Educational/Qualification/Experience:- Pharmacist- Minimum 3-5 years experience in regulatory affairs in pharmaceutical companies- Fluent in English(writing & speaking)
´ã´çÀÚ : (ÁÖ)¸¶ÀϽºÅæ¼Ä¡ ¿øÇö¼÷»ó¹«(www.mstone.co.kr)¿¬¶ôó : 02-2050-0299, 010-8911-5018À̸ÞÀÏ : hs@mstone.co.krÁö¿ø½Ã Á¦Ãâ¼·ù : ±¹¿µ¹®À̷¼, ÀÚ±â¼Ò°³¼
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