15 days old

Regulatory Affairs Associate (12

North Wilkesboro, NC 28659
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Reporting to the Head of Regulatory Affairs, the incumbent is responsible for all local regulatory activities for the assigned product portfolio.


+ 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


+ 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
Posted: 2020-05-11 Expires: 2020-06-11
Sponsored by:
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Regulatory Affairs Associate (12

North Wilkesboro, NC 28659

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