Description

• Product Registration & Maintenance
• Set up registration strategy according to the launch strategy of NME.
• Develop bridging strategy to obtain marketing authorization from MFDS in collaboration with GRA and local cross-functional team.
• Prepare MFDS application according to the local regulation/requirements/SOP and ensure filings and approval.
• Secure product license by updating CMC, CCDS, and safety information.
• Review promotional materials to comply with local regulation and Sanofi SOP.
• Manage business licenses appropriately.
• Regulatory intelligence and policy shaping in align with Sanofi strategy.
• Provide relevant regulatory consultation and insight to internal functions.
• Collaborate with other functions for cross-functional projects based on regulatory environment.
• Foster, establish and maintain close working relationships with MFDS, MoHW and trade associations.
• Establish and maintain effective working relationships with internal and external stakeholders.

Qualifications

Minimum 2+ years experience in regulatory affairs for RA specialist/Sr. RA Specialist (depending on the experience level of the candidate)
Soft Skills

• Good communication & interpersonal skills
• Strong collaborative ability and dedication to team accomplishment
• Drive to succeed (individually and as a team) with a strong work ethic
• Innovative strategic thinker
• Agile mindset

Technical Skills

• Good knowledge of regulations of pharmaceutical affairs
• Comprehensive knowledge in pharmacy

Education: Pharmacist or University degree in life science

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