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[Sanofi/»ç³ëÇÇ] RA Specialist
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https://sanofi.wd3.myworkdayjobs.com/SanofiCareers/job/Seoul/Regulatory-Affairs-specialist_R2523981
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[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
• Corporate 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
− Set up registration strategy and timeline according to the launch strategy of NCE/NBE.
− Develop bridging data to obtain marketing approval from Ministry and Drug Safety (MFDS) in collaboration with GRA and Medical.
− 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.
• Prepare IND application in consistent with MFDS requirements and obtain IND approval to ensure study timeline in collaboration with CSU.
• Review promotional 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 comparator intelligence.
− Foster, establish and maintain close working relationships with MFDS, MoHW and industry associations.
• Establish and maintain effective working relationships with internal and external stakeholder
[Key ¡°MUST HAVE¡± competencies, skills & experiences]
Language skills:
Fluent Korean and English (reading, writing and speaking skill)
Education:
University degree in Life science or pharmacist
Experience & knowledge:
- Minimum 4 years of experience in pharmaceutical Industries
- Knowledge in pharmaceutical regulation
- Comprehensive knowledge in pharmacy
Core competencies:
- Good communication, presentation, and negotiation skills
- Competitive skill in softwares (word, excel, powerpoint)
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02-2136-0000
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