13 days old

Regulatory Affairs Associate (12

Pfizer
North Wilkesboro, NC 28659
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**POSITION PURPOSE** The Position is responsible for all Hong Kong and Macau regulatory activities for the assigned product portfolio.



**ORGANIZATIONAL RELATIONSHIP** Direct report to Head of Regulatory Affairs, North Asia Cluster /HK



**RESPONSIBILITIES**

**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.



**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.



**Requirement**



+ Degree holder in Life Science or related disciplines, with relevant job experience in pharmaceutical industry is preferred

+ Excellent oral and written communication skills

+ Good interpersonal and communication skills

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

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



\#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: 2020-10-13 Expires: 2020-11-26
Sponsored by:
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Regulatory Affairs Associate (12

Pfizer
North Wilkesboro, NC 28659

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