About the job
Job Purpose/Priorities:
Ensure that product registration or business licenses are obtained and maintained in line with the business plan and in compliance with local regulation and SOP.
Ensure that regulatory strategy is set-up and executed in align with GRA strategy and launch strategy.
Provide regulatory supports to other functions.
Main responsibilities:
- 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.
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Experience: more than 5 years' experience in regulatory affairs
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
- - Good knowledge of regulations of pharmaceutical affairs
- - Comprehensive knowledge in pharmacy
Languages: Fluent Korean and English (reading, writing, and speaking skill)