Pfizer Senior Regulatory Affairs Specialist in Seoul,

Senior Regulatory Affairs Specialist:

신약 및 R&D 중심의 PIH (Pfizer Innovative Health) 사업부 제품을 전담하는 Sr. RA Specialist

Qualifications:

 - Regulatory Affairs 경력 3년 이상 선호

 - 학사 이상 (약학/의학/자연과학 전공 선호)

 - Fluency in written and spoken English

 - Negotiating, communication and interpersonal skills

 - Working knowledge of computer applications

Refer to below Job Description for more information The Senior Regulatory Affairs Specialist is responsible for assisting in timely and efficiently managing drug registration process from beginning to end in accordance with regulatory requirements.

This position reports directly to Regulatory Affairs Manager.

  • Partners with relevant development/commercial team within the PPKL (Clinical, Medical, Business Development, Corporate Affairs, Quality Operations, Logistics and Legal).

  • Partners with WRD/WSR- I & Global Product Info/HQ RA as well as other countries' regulatory staffs.

  • Works with external contacts in the Ministry of Food and Drug Safety (MFDS), as well as relevant experts and key opinion leaders.

Primary Responsbilities

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

  • Assists Regulatory Affairs Manager 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.

Qualifications

  • Experience in CTA (clinical trial application) is preferred

  • 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

*Applications close 6pm, July 27, 2018

*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.