- 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
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs -
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Senior Regulatory Science Specialist - Seoul, 대한민국. - Pfizer
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