Pfizer RA Specialist & Sr. RA Specialist & RA Manager in Seoul,

1. RA Specialist

Responsibility

  • 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 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.

  • 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, Medical, Business Units, Corporate Affairs, Quality Operations, and WRD/WSR- I & Global Product Info/HQ RA.).

  • 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 Regulatory Affairs Team Lead to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).

  • Assists Regulatory Affairs Team Lead for coordinating regulatory activities between Divisions/Business Units and timely communications with WRD/WSR- I & Global Product Info/HQ RA.

  • Supports and collaborates with Business Groups for related works.

Skill

  • Professional Expertise

  • Decision-making/ Judgment

  • Negotiation

  • Analytical Thinking

  • Project Management

  • Teamwork

Qualification

  • Bachelor's degree in a scientific field required

  • Negotiating, communication and interpersonal skills

  • Working knowledge of computer applications

  • Fluency in written and spoken English

2. Sr. RA Specialist

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 updates 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/WSR I & Global Product Info/HQ RA).

  • 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 Affairs Team Lead. to establish, develop and maintain close working relationships with the relevant regulatory authorities and associations (MFDS, MOHW, KRPIA etc.).

  • Assists Regulatory Affairs Team Lead. for coordinating regulatory activities between Divisions/Business Units and timely communications with WRD/WSR- I & Global Product Info/HQ RA.

  • Supports and collaborates with Business Groups for related works.

Skill

  • Professional Expertise

  • Decision-making/ Judgment

  • Negotiation

  • Leadership

  • Project Management

  • Teamwork

Qualification

  • 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

3. RA Manager

Responsibility

  • 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) in full compliance with all relevant legislation and SOPs.

  • 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 updates 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 Groups, Corporate Affairs, Quality Operations, and WRD/WSR- International & Global Product Info/HQ RA).

  • Coaches and trains RA Specialist/Senior RA Specialist.

  • Supports and collaborates with Business Groups for related works.

Skill

  • Professional Expertise

  • Decision-making/ Judgment

  • Negotiation

  • Leadership

  • Strategic Thinking

  • Teamwork

Qualification

  • Bachelor's degree in a scientific field required

  • Strong negotiating, communication and interpersonal skills

  • Working knowledge of computer applications

  • Fluency in written and spoken English

  • Minimum experience of 4 years in regulatory affairs

Application Deadline: March 26th (Tuesday) 6:00 pm

Please apply via Pfizer Career Website Only.

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