-Prepare submissions for the new product registration
-Initiate, track and facilitate new product registrations and achieve on-time approvals
-Ensure maintenance of registered product license
-Maintain a close working relationship with Government authorities (MFDS, Testing Agencies) for the product registration
-Monitor regulatory environment changes, and provide impact analysis plus action plans to ensure compliance
-Assist Regulatory Affairs Manager to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations
-Assists Regulatory Affairs Manager for coordinating regulatory activities between Divisions/Business Units and have timely communications with BU RA, Regional RA
-Assist Regulatory Affairs Manager for on-site inspection to PU performed by MFDS
-Timely update and regularly check global RA database, RegTrack and Sharepoint
-Proofreading the Label & PIs
경력 및 자격요건
-Qualification of pharmacist in bachelor or higher degree
-Minimum 10 years in regulatory affairs of Pharmaceutical
-Effective communication skill
-Negotiating and persuading skill
-Comprehensive knowledge of pharmaceutical regulations
-Good computer skill
-Fluent written and spoken English
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
