▣ 채용 포지션 : 제약사업부 Sr. RA Specialist
< Primary Job Function > -Registering new products and managing existing products by leveraging a current and changing regulatory environment. -Liaising, responding to, and negotiating with regulatory authorities. -Support business planning activities by providing of smart registration strategy. -Compliant with the current ** procedure. -Leading regulatory compliance management.
< Core Job Responsibilities > -Achieve registration approval for planned new products and ensure subsequent maintenance of existing drugs on time. -Provide the best registration strategy and timeline and communicate it with stakeholders. -Secure product license maintenance according to local regulations and global ** compliance standards. -Understand the regulatory environment changes and prepare for the implementation in compliance with the new regulation and ** procedures. -Provide proper and exact Regulatory related information to stakeholders. -Maintain well-managed external communication with related Health Authorities. -Review registration requirements upon request by internal stakeholders. -Leading regulatory compliance management: regular monitoring & implementing actions for RA systems as trainer level. Analyzing regulations and environment, and keeping stakeholders updated.
< Position Accountability / Scope> -Product/Business license registration, maintenance, and relevant regulatory activities for Pharmaceutical Products (chemical & biologics). -Communication with the global and local stakeholders regarding the RA topics. -Promotional material review for the assigned products. -Compliance with the **procedures, performing the related activities.
< 자격요건 > - 대졸이상 (약학 우대 / 관련전공 선호 ) - 다국적기업 경력자 선호 - 제약사업 RA 7년이상 ~ - 영어 상급
▣ 전형방법 : 서류전형>면접(1차실무/2차임원)>OFFER협의>최종결과발표 ▣ 제출서류 : 영문(필수) 이력서 및 경력중심 자기소개서 (MS워드 형식) ▣ 제출방법 : ymlim@plus-hr.co.kr 로 이메일 접수 -. 최종연봉, 희망연봉 필히 기재 -. 첨부 표준이력서양식 사용 권장
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전형절차
ㆍ서류전형 > 1차면접 > 2차면접 > 임원면접 > 최종합격
ㆍ면접일정은 추후 통보됩니다.
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유의사항
ㆍ허위사실이 발견될 경우 채용이 취소될 수 있습니다.
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