JOB SUMMARY

The Senior Regulatory Science Specialist is responsible for timely and efficiently managing drug registration process from beginning to end in accordance with regulatory requirements.

JOB RESPONSIBILITIES

• Prepares filings and obtains marketing approval from the MFDS for a planned new drug (K-NDA) and ensures subsequent maintenance of drugs registered (Supplemental & Amended K-NDA).
• Ensures quality filings of K-IND submission and its approval.
• Updates the assigned Local Product Documents (LPDs) in consistent with the local regulations and CDS update, and ensures timely updates for the related systems (e.g. PEARL, GDMS, and etc.).
• Provides regulatory science related information to other divisions/departments.
• Is aware of the external regulatory environment, including competitor intelligence and regulatory actions, in order to provide informed input to regulatory strategies.
• Coordinates regulatory activities between divisions/departments (Clinical, Medical, Business Units, Corporate Science, Quality Operations, and PRD etc.).
• Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
• Assists Regulatory Science Team Lead. to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).
• Assists Regulatory Science Team Lead for coordinating regulatory activities between Divisions/Business Units and timely communications with PRD etc..
• Supports and collaborates with Business Groups for related works.

• Pharmacist (Pharm.D) or Master's degree in a scientific field
• Minimum 2 years experience in pharmaceutical industry for Bachelor's degree in a scientific field
• Negotiating, communication and interpersonal skills
• Working knowledge of computer applications
• Fluency in written and spoken English

• Professional Expertise
• Decision-making/ Judgment
• Negotiation
• Leadership
• Project Management
• Teamwork