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[Sanofi/»ç³ëÇÇ] RA Specialist
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https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Seoul/Regulatory-Affairs-Specialist_R2534070
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Position Title: Regulatory Affairs Specialist
Business Unit: Regulatory Affairs
Manager¡¯s Title: RA manager
Location: Seoul, Korea
JOB PURPOSE/PRIORITIES:
• Ensure that product registrations are obtained and maintained in line with the plan
• Ensure that the business licenses are obtained and maintained appropriately
• Provide appropriate regulatory supports to other departments
ORGANIZATIONAL CONTEXT:
• Report to the RA manager
•Global RA: Exchange all relevant information and documents (strategy, dossier, plan) and advise.
•Concerned departments
- MKT : exchange all relevant information and documents and advise
- MI/PV : close contact regarding data sheet and drug safety information
- Medical: close contact regarding medical information
- CSU : close contact regarding IND application and development strategy
- QA : close contact regarding CMC information
- SCM dept. : close contact regarding package materials and reg. plan
- MA/PA: close contact regarding market access/government affairs
KEY ACCOUNTABILITIES:
• Product Registration & Maintenance for OTC products
− Set up registration strategy and timeline according to the launch strategy
− Prepare MFDS application according to the local regulation/requirements/SOP and ensure filings submission and approval.
− Secure product license by updating CMC, CCDS and safety information.
• Review promotional materials and package materials to comply with local regulation and Sanofi compliance.
• Manage business licenses appropriately.
• Regulatory Intelligence
− Provide relevant regulatory information and insight to other departments.
− Collaborate with other divisions for related works based on regulatory environment including competitor intelligence.
− Foster, establish and maintain close working relationships with MFDS and industry associations.
Qualification
• University degree in Life science, pharmacy etc.
• More than 3 years¡¯ experience in regulatory affairs
• Knowledge in OTC regulation and industry
• Good communication, presentation, and negotiation skills
• Competitive skill in softwares (word, excel, powerpoint)
• Fluent in Korean and English (reading, writing and speaking skill)
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02-2136-0000
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