Job Description

Job Responsibility

• Assists in filing and obtaining 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 ensure timely update notifications for the related systems (e.g. PEARL, GDMS, and etc.).
• Provides regulatory affairs 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.
• Establishes, develops and maintains close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).
• Coordinates regulatory activities between divisions/departments (Clinical, Medical, Business Units, Corporate Affairs, Quality Operations, and WRD/ GPD etc.).
• Ensures registered products are maintained and updated in full compliance with all relevant legislation and SOPs.
• Provides regulatory affairs related information to other divisions/departments.
• Is aware of the external regulatory environment, including competitor intelligence and regulatory actions, to assist practical regulatory strategy development.
• 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 WRD/ GPD etc.
• Supports and collaborates with Business Groups for related works.

Qualifications

• Bachelor’s degree in a scientific field required
• Minimum 2 year experiences
• Negotiating, communication and interpersonal skills
• Working knowledge of computer applications
• Fluency in written and spoken English
• Minimum experience of two years in regulatory affairs

Skills

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.