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Pfizer Regulatory Affairs Associate (12 in Quarry Bay, Hong Kong

Reporting to the Head of Regulatory Affairs, the incumbent is responsible for all local regulatory activities for the assigned product portfolio.

Responsibilities

  • Assist in registration, renewal, line extension, and change of registered particulars of our Company products promptly and efficiently with necessary status report and continual update to supervisor

  • Liaise closely with regulatory and manufacturing groups to ensure our products, including labeling, 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

  • Ensure the database is up to date and meet the requirements according to Pfizer's SOP

  • Maintain necessary record-keeping on regulatory related issues

  • Provide supporting documents for the government/Hospital Authority tender applications

  • Provide supporting documents for Macau importation and tender applications

  • Assist in tasks and duties as required under wholesale dealer license

  • Ad-hoc projects of other technical functions and as assigned

Requirement

  • University graduate preferably in Pharmacy, Biological Science, Medical Science or related disciplines

  • Experience in the pharmaceutical industry is desirable

  • Detail-oriented, well organized, highly motivated, mature and a good team player

  • Good interpersonal and communication skills

  • Strong organization skills, ability to coordinate with colleagues and external parties at all levels

  • Able to work under pressure with stretching timeline and in a dynamic environment

  • Proficiency in Chinese and English#LI-PFE

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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