[글로벌 유명 제약사] RA Support

[기업 소개]

외국계 유명 제약사

[업무 내용]

JOB PURPOSE
• Ensure that product registrations are obtained and maintained in line with the plan
• Ensure that the business licenses are obtained and maintained appropriately
• Provide appropriate regulatory supports to other departments

ORGANIZATIONAL CONTEXT
• Report to RA manager
• Interaction with Global RA: Registration strategy discussion, Dossier dispatch, and Regulatory compliance etc.
• Interaction with other local functions
KEY ACCOUNTABILITIES
• Preparation of registration dossier for submission to MFDS  - New products registration and variations (e.g. CMC, labeling, safety etc)
• Preparation of IND dossier for clinical study
• Translation of registration dossier (non-clinical, clinical, CMC dossier)
• Support regulatory database update (local and global database)
• Archive and report regulatory activities and documents
• Review of package artwork  and promotional materials

[근무조건]

- 기간:  파견 계약직 1년 (이후 연장 가능)

- 급여: 경력에 따라 협의 / 희망급여 제시

- 지역: 서울시 강남구 3호선 / 7호선 고속터미널역 인근

- 시간: 평일 9시 ~ 18시

- 기타: 4대보험 가입, 연차휴가, 퇴직금, 경조금 , 경조휴가 , 명절선물 , 생일자 상품권등  지급 등 내규에 따름

[자격 조건]

JOB-HOLDER REQUIREMENTS
• Education:  University degree in Life science or Pharmacist
• Experience & knowledge:
• - 1 to 2 year experience in pharmaceutical industries
• - Knowledge in pharmaceutical regulations
• - Comprehensive knowledge in pharmacy
• 
• Core competencies /skills:
• - Fluent in Korean and English (verbal and written communication)
• - Good communication, presentation, and negotiation skills
• - Competitive skill in basic softwares (word, excel, powerpoint etc)

[지원방법]
- 메일접수시 제목에 외국계 제약사 _  RA Support   _성함` 기재 바랍니다.
** 적합자 지원시 서류전형 조기마감 되실 수 있으므로, 빠른 이력서 접수 부탁 드립니다.

[담당자]
김민경 차장 760-8863 / mk.kim@kellyservices.kr

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