Responsibilities 
- Preparing the registration dossiers in eCTD format (INDs, NDA and DMF).
- Developing the regulatory strategy of the registration of different products in South Korea.
- Performing quality control checks for submission ready documents.
- Participating in regulatory-clinical cross functional team meetings and project teams.
- Preparing responses to MFDS queries as needed
- Gathering and assembling information necessary for submissions in accordance with MFDS Regulations and relevant guidelines.
- Developing timelines for submissions and tracking the regulatory deliverables.
- Providing Regulatory Affairs support during internal and external audits.
- Defining regulatory deliverables for each project and monitoring projects through completion
- Assisting in the development of best practices for Regulatory Affairs processes.
- Supporting GRP Clients in South Korea.
- Reporting the regulatory activities to GRP CEO on regular basis

Qualifications
- Authorized Pharmacist in south Korea.
- Bachelor degree in the Life Sciences or a related field, and self-starting ability with excellent written and verbal communication skills.
- At least 6 to 8 years-experience working as Regulatory Affairs Manager in South Korea for pharmaceuticals or biotech company in South Korea.
- Proficiency in MS Word, MS Excel, and Adobe Acrobat is essential.
- Good understanding of the drugs registration process,
- Has prepared and submitted at least 1 NDA and 1 IND to MFDS
- Working knowledge of industry legislation and best practices
- Good project management skills - Good communication in English and writing in English.
- Document management, or equivalent technical experience.
- Ability to work in a fast-paced environment that is primarily timeline-driven.
- Ability to manipulate large and complex documents required for submissions.
- Attention to detail with the ability to multi-task.

*국문 이력서,경력기술서  및 영문이력서,경력기술서 병행 송부