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Subject 글로벌 제약사 - Regulatory Affairs Specialist
Date 2022.03.07
▣ Company: 글로벌 제약사


▣ Position: Regulatory Affairs Specialist


▣ Responsibilities
- Obtain registration approval and lifecycle management of approved products
- Adherence to relevant regulations and guidance that affect both development and marketed products
- Inform Global RA of country specific requirements for product and site registrations
- Assess the registration file for acceptability to local requirements and requesting additional documentation from Global RA
- Inform Global RA as soon as possible if regulatory actions are imposed by local authorities
- Monitor of regulatory intelligence in the country, evaluating potential regulatory impact and informing Global RA
- Timely annual report submission such as product, DMF and registered overseas manufacturing site etc.
- Handle the request from authority such as safety information update, data submission request etc.



▣ Requirements
- Bachelor’s degree in pharmacy or life science
- 5+ years of Regulatory Affairs experience is preferred
- Effective research and analytical skills
- Effective written and oral communication, technical writing and editing skills


▣ Location : 서울


▣ 제출서류
- 이력서를 MS Word 파일로 담당 컨설턴트 Email로 보내주시기 바랍니다.
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