As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
업무 책임:
Import license application(시험용 의료기기 확인서) 및 변경/보고 관리
Tracker 및 데이터베이스 관리 및 팀 회의 조율 등의 Team support 업무
Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions
Provide basic regulatory affairs services including preparing submission packages
Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
Develop a familiarity with current global regulatory submission standards
Develop a familiarity with departmental standard operating procedures and work instructions
(Regulatory Affairs only) Under supervision provide support to currently marketed products
자격 요건:
0-2 years’ experience in an industry-related environment
Bachelor’s Degree in a Scientific or Technical Discipline