[모집개요]
회사 : 외국계제약회사
포지션 : RA Specialist
회사위치 : 서울 강남
[모집부문]
직위 : 대리급
담당업무 : 외국계제약회사에서 RA Specialist를 찾고 계십니다. 근무지는 서울 강남입니다.

Essential Duties and Responsibilities:
1. Make a plan for the product approval and maintain the marketing authorization including PMS study, variations, annual reports and any regulatory process for both stages of pre-approval and post-approval.
2. Execute preparations of the application files and follow ups for marketing authorization approval.
3. Monitor Korean regulations and trend of global regulations and standards to ensure that Company systems comply with requirements for import and distribution of pharmaceuticals, medical devices, functional food and cosmetics, ensuring compliance with the most stringent applicable laws and regulations. Create and modify policies and procedures as required for compliance.
4. Oversee the Recall and Field Corrective Action systems, ensuring appropriate documentation and reporting to the necessary authorities as required.
5. Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
경력요건 :
Position Requirements
- Pharmacist license is required
- At least 4 years experience in a lead regulatory role at pharmaceutical company
- Pharmaceutical drug registration experience is mandatory (의약품등록업무 2년 이상)
- Extensive experience in performing all regulatory functions international registrations and reviewing documentation for regulatory compliance.
- Hands on experience with preparation of CTD submissions for drugs and technical files for medical devices required.
- 영어 가능하신 분
연령 : .
학력 : 정규대졸 이상
어학 : 영어
컴퓨터 : .
연봉 : .
특이사항 : 약사
[담당자/문의처]
담당자 : 고정윤과장
전화 : 02-2050-0297
제출서류 : 국영문이력서
전자우편 : position@mstone.co.kr