Pfizer Regulatory Affairs Associate in Quarry Bay, Hong Kong

POSITION PURPOSE

The Position is responsible for all Hong Kong and Macau regulatory activities for the assigned product portfolio.

RESPONSIBILITIES

  1. REGISTRATION
  • To achieve registration of our Company products promptly and efficiently with necessary status report.

  • To develop and maintain good relationship with Department of Health to facilitate the approval and registration processes.

  • To ensure product registration renewal, line extension, and any change of registered particulars are achieved in a timely manner with continual update to supervisor.

  1. REGULATORY COMPLIANCE
  • To liaise closely with regulatory and manufacturing groups to ensure our products, including labelling, artwork and the finished products, are complied with local regulatory requirements and Pfizer's guidelines.

  • Collaborate with Medical, Commercial and Supply Chain to ensure our products on the market are complied with current registration.

  • To follow necessary approval procedures in updating Local Product Documents (LPD) as per local regulatory requirements and Pfizer's SOP.

  • To liaise closely with Medical, the relevant business unit and corresponding publisher to ensure regulatory information relating to our products in all relevant compendia, including but not limiting to MIMS, are up to date.

  • To ensure the database in Product Event And Registration Licenses system (PEARL)is up to date and meet the requirements according to Pfizer's SOP.

  • To maintain necessary record-keeping on regulatory related issues.

  • To provide supporting documents for the government/Hospital Authority tender applications.

  • To provide supporting documents for Macau importation and tender applications.

  • Ad-hoc projects assigned by Line Manager.

3. ORGANIZATIONAL RELATIONSHIPS

  • Direct Report to Head of Regulatory Affairs

4. TECHNICAL SKILL REQUIREMENTS

  • Detail-oriented, well organized

  • Highly motivated, mature and a good team player

  • Good interpersonal and communication skills

  • Good negotiating skills

  • Prior knowledge of local regulatory environment and regulations is highly desirable.

QUALIFICATIONS

  • Degree holder in Life Science or related disciplines

  • Excellent oral and written communication skills

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