-Provide strategic input into the development of assigned projects handling complex issues, seeking
guidance where appropriate.
-Ensure input from cross functional team members and issues regulatory plans as appropriate.
-Attendance at project teams representing RA team as appropriate.
-Prepare regulatory filings for submission to regulatory agencies.
-Manage strategy for response to regulatory agency queries, ensuring scientific dossier content and
consistency of scientific content and Company position across geographic areas.
-Develops, rewards and shares talent;
-Coordinate assigned workload planning & prioritization and performance
-Monitor actual vs. planned activities and timelines.
-Identify issues impacting project progression and work with manager to recommend improvements to correct or
accelerate project progression
-Prepare and present written and oral reports and other presentations to team members and other internal
audiences. Adjusts presentation style and content to suit the audience.
-Manage the preparation and review of technical strategic regulatory documentation for agency submission.
-Responsible for ensuring accuracy and quality of documentation.
경력 및 자격요건
Minimum Education:
Bachelor's Degree in pharmacy, or related subject
Minimum Experience/Training Required:
10+ years in pharmaceutical industry including over 8+ years RA experience
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
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02-6281-5049
kevin108@nterway.com
