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Regulatory Affairs Associate

Pfizer


Location:
Sejong-daero, Seoul 110-050
Date:
01/06/2018
2018-01-062018-02-06
Pfizer
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Job Details

Fixed Term Colleague (~2018.08.31)







- Data cleaning and related remidiation activities for Regulatory affiars related database.



- Supporting product license maintanance activities (including labeling, CMC update) and update related databases.



-Refer attached JD as well.







**Primary Responsibilities**







+ Assists in filing and obtaining marketing approval from the Ministry of Food and Drug Safety (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 under supervision.



+ Updates the assigned Local Product Documents (LPDs) in consistent with the local regulations and CDS update and updates the related databases (PfLEET, GDMS, local LPD drive).



+ 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.



+ Assists to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).



+ Coordinates regulatory activities between divisions/departments (Clinical Trial Support & Compliance, Business Units, Public Affairs, Quality Operations, and Global Product Info/ PEH R&D) under supervision.



+ Assists registered products are maintained and updated in full compliance with all relevant legislation and SOPs.



+ Provides regulatory affairs related information to other divisions/departments.



+ Assists Head of Regulatory Affairs to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).



+ Assists Head of Regulatory Affairs for coordinating regulatory activities between Divisions/Business Units and timely communications with relevant Hub organization, Global Product Info/HQ RA.



+ Supports and collaborates with Business Units for related works.







**Qualifications (i.e., preferred education, experience, attributes)**







+ Bachelor's degree in a scientific field required



+ Negotiating, communication and interpersonal skills



+ Working knowledge of computer applications



+ Fluency in written and spoken English







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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