- 이미지뷰 -
[Sanofi/사노피] RA Specialist
제출 서류: 국/영문 이력서 및 자기소개서를 하나로 통합하여 MS Word 또는 PDF로 첨부 해주십시오
지원 문의: 이메일 email@example.com
두개 포지션 채용중에 있으며 JD와 지원 링크가 상이하오니 참고 바랍니다.
1) RA Specialist
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
(See Organizational chart attached)
• 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
• 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 stakeholders
Key “MUST HAVE” competencies, skills & experiences
Fluent Korean and English (reading, writing and speaking skill)
University degree in Life science or pharmacist
Experience & knowledge:
- 1 to 2 years’ experience in pharmaceutical Industries
- Knowledge in pharmaceutical regulation
- Comprehensive knowledge in pharmacy
- Good communication, presentation, and negotiation skills
- Competitive skill in softwares (word, excel, powerpoint)
2) RA Specialist
· ProductRegistration & Maintenance : Health Functional Food and Medicines
− Setup registration strategy and timeline according to the launch strategy
− PrepareMFDS application according to the local regulation/requirements/SOP and ensurefilings submission and approval.
− Supportimport and marketing activities of Health Functional Food
− Securemedicinal product license by updating CMC, CCDS and safety information.
· Reviewpromotional and package materials to comply with local regulation and Sanoficompliance.
· Managebusiness licenses appropriately.
− Providerelevant regulatory information and insight to other departments.
− Collaboratewith other divisions for related works based on regulatory environmentincluding comparator intelligence.
− Foster,establish and maintain close working relationships with MFDS and industryassociations.
· Universitydegree in Life science, pharmacy etc.
· 2to 3 years’ experience in Health Function Food registration
· Knowledgein health functional food regulation and industry
· Goodcommunication, presentation, and negotiation skills
· Competitiveskill in softwares (word, excel, powerpoint)
· Fluentin Korean and English (reading ,writing and speaking skill)
지원자 자유이력서 양식
[137-040] 서울 서초구 반포동 반포대로 235
최종수정일 : 2019년 08월 06일
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제휴 및 광고문의
설립일 : 2015년 12월 02일 l 개인정보책임자 : 윤병호
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