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※ This position opening has been closed If you have any inquiry, please contact the consultant directly for more information. |
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| :: Regional Regulatory Manager :: | |
| Company Introduction | 국내 최대 진단,의료기기,의약품 기업 |
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| Job Description | -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. |
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| Job Requirement | 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 |
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| Location | 서울|서울 | Degree Level | 대졸이상 |
| Career Level | [부장급][차장급] | ||
| No. of Recruitment | 1 | ||
| Salary | 업계수준 | ||
| Required Document | 회사에서 요청한 워드 양식 | ||
| Others | - 원서 마감후 1차(서류) 합격자에 한하여 개별연락 - 제출된 서류는 일체 반환하지 않습니다. - 해외여행에 결격 사유가 없는 자 - 이력서에 연락처, 희망연봉 게재 |
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| Contact/Inquiry | 이철훈 / 이사 02-6281- 5049 kevin108@nterway.com |
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