- 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
경력 및 자격요건
- Preferred majors in priority : pharmacy, medical science, biology, etc.
- Minimum 3 years in regulatory affairs of Pharmaceutical
- Effective communication skill
- Comprehensive knowledge of regulation
- 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
