외국계 제약사 Sr. RA

▣ 채용 포지션 : 제약사업부 Sr. RA Specialist


-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.


-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.


-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.


- 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