This position will be either RA specialist or Sr. RA specialist depending on the experience level of the candidate. **Our Team:** 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. + 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. **Experience:** 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) **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)