-Prepare submission for new product resistration
-Initiaate, track and faciliate new product resigtrations and achieve on-time approvals.
-Ensure maintenance of resigtered product license
-Maintain a close working relationship with Government authorities for the product resigtration
-Monitor regulartory environment changes, and provide impact analysis plus action plans to ensure compliace
-Assist Regulartory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulartory authorities and assosiates
-Assists Regulartory Affairs Manager for coordinating regulartory activities between Divisions/ Business Units and have timely communications with BU RA, Regional RA
-Assists Regulartory Affairs Manager for on-site inpection to PU performed by MDFS
-Timely update and regularly check gloval RA database, RegTrack and Sharepoint
-Proofreading the Label & PIs
경력 및 자격요건
-At or above graduation of 4year university
-Preferred majors in priorty: Pharmacy, medical science, biology, etc
-Minimum 1years in regulartory affairs of pharmaceutical
-Fluent written and spoken English
-Good computer skill
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
