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¹®ÀÇ»çÇ×Àº minjung.choi@merck.com À¸·Î º¸³»ÁÖ½Ã¸é °¨»çÇÏ°Ú½À´Ï´Ù.
Responsibilities
Obtainthe regulatory approval timely through the best registration strategy, andmaintain product license with local regulation and global compliance standard.
1.Achievetimely registration of new products and their variations/updates
-Prepareand submit registration dossier in accordance with the plan
-Communicateeffectively with the Agency, HQ and appropriate experts
2.SupportRegulatory Affairs Manager to develop assigned product specific plans andregistration strategies
-Analyzeregulatory and product information
-Defineand anticipate potential issues
3.Maintainproduct licenses
-Updatesafety and quality information timely
-Meetthe compliance for global RA database
-Follow up post-approval activities(re-examination, DMF, annual report, etc.)
Requirements
[°øÅë ÀÚ°Ý ¿ä°Ç]
•Functional Knowledge: DrugDevelopment, Local/Global regulatory environment, Structure or functions ofpharmaceutical industry
•Skills: Strategic focus,Communication & Negotiation, Project management Skills, Coaching skills, Fluentwritten & spoken English
•Leadership Behaviors:Commitment/Self-discipline, Make rapid and disciplined decision, Fostercollaboration, Build talent, Customer/Quality/Compliance focus
•Education: Pharmacy majoris preferred
[Æ÷Áö¼Ç º° ÀÚ°Ý ¿ä°Ç]
•Sr. RA Specialist:More than 7 years of RA experience, Candidate with experience in QA/ClinicalTrials/PV/Medical field can be considered
•RA Specialist: More than 2 years ofRA experience, Candidate with experience in QA/Clinical Trials/PV/Medical fieldcan be considered
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