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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/CA: close contact regarding market access/Corporate 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.
  • Product Registration & Maintenance
  • 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

JOB-HOLDER ENTRY REQUIREMENTS:

Language skills:

Fluent Korean and English (reading, writing and speaking skill)

Education:

University degree in Life science or pharmacist preferred

Experience & knowledge:

  • (newcomer ~) up to 5 years’ experience in pharmaceutical Industries
  • Knowledge in pharmaceutical regulation
  • Comprehensive knowledge in pharmacy

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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Confirmed 23 hours ago. Posted 14 days ago.

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