Senior Regulatory Science Specialist

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.

QUALIFICATIONS

• 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

SKILLS

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

Work Location Assignment: Hybrid

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

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