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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. - 이력서에 지원분야의 경력 사항을 최대한 구체적이고 상세히 기술해 주시길 바랍니다. - 사진 첨부요망 / 응시분야 / 연락처 / 연봉(현 연봉 & 희망 연봉) 기재
▣ Contact point : 박경정 이사 If you have any question, please do not hesitate to contact me. Office : 02-508-7484 // Email : kjpark@hennymccoy.com Home : www.hennymccoy.com ** 이메일로 접수바랍니다 (온라인으로 지원할 경우 확인이 늦어질 수 있음)**
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