Regulatory Affairs Specialist

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.

• 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.

About You

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

​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)