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.