[모집개요]
회사 : 외국계제약회사
포지션 : Sr. RA Specialist & RA Specialist
회사위치 : 강남
[모집부문]
직위 : 대리-과장급
담당업무 : 외국계제약회사의 제약사업부에서 Sr. RA Specialist와 RA Specialist 두분을 찾고 계십니다.

Sr. RA Specialist는 과장급이며, RA Specialist는 대리급입니다.

Reporting은 Regulatory & Scientific Affairs Director에게 하십니다.

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 company
personnel.

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
경력요건 : Educational/Qualification/Experience
Pharmacist
Minimum 3-5 years experience in regulatory affairs in pharmaceutical companies
Fluent in English(writing & speaking)
연령 : 30대 초반-중후반
학력 : 정규대졸
어학 : 영어
컴퓨터 : MS office
연봉 : 협의
특이사항 : .
[담당자/문의처]
담당자 : 원현숙상무
전화 : 02-2050-0299
제출서류 : 영문이력서, 자기소개서
전자우편 : hs@mstone.co.kr