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외국계 제약회사 |
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| 모집부문 |
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RA Specialist |
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| 모집인원 |
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0명 |
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| 업무내용 |
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- 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 |
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| 지원자격 |
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- Minimum 2 years experience in regulatory affairs in pharmaceutical companies
- Good Command of English |
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| 근 무 지 |
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서울 |
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| 경......력 |
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3년이상 |
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| 학......력 |
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대졸이상(4년) |
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| 성......별 |
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무관 |
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| 연령제한 |
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| 연......봉 |
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Nego. |
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| 모집기간 |
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~ 13. 10. 15 까지 |
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| 전형방법 |
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1차 서류전형 2차 면접 |
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| 제출서류 |
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국,영문 이력서 및 경력 중심 자기소개서 |
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| 담......당 |
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고재익 |
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| 전화번호 |
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02-597-1780 |
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| 기타사항 |
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[접수방법] E-mail : jiko01@kohuman.com (이메일접수만 가능) |
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| 설립연도 |
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| 기업규모 |
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| 회사설명 |
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외국계 제약회사 |
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