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Regulatory Affairs Associate

Description

Want to think for yourself? As Regulatory Affairs Associate you’ll have the freedom to forge a career as an expert in a niche, in-demand, business-critical role.  
 
Regulatory Affairs Associate 
Hong Kong, Hong Kong 

 

 

Accountability:

•Provide support to the regulatory activities for all products within Hong Kong
•Compilation of national dossiers for submissions to authorities
•Support the preparation, maintenance and update of product registration/license and regulatory compliance files.
•Support the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals.
•Developing and maintaining a database of local regulatory requirements.
•Manage assigned product portfolio
•Work with Head of Regulatory and Medical Affairs to execute activities in Hong Kong 
•Support local artwork creation and proof-reading 
•Support local advertisement and promotional activities to ensure compliance to local regulations
•Support responses on product queries to internal and external customers
•Provide supporting documents for Macau importation and cross-border business

 

Requirements:

•University graduate in biological science / pharmacology
•Minimum 1-2 years’ experience in regulatory affairs, with FMCG, pharmaceutical, medical device experience has advantage
•Results oriented, entrepreneurial and self-motivating 
•Good analytical and organizing skills
•Detail oriented and able to work independently  
•Work under pressure and tight timeline  
•A team player with good communication and interpersonal skills 
•Good command of written and spoken English and Chinese

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Job Segment: Medical Device, Healthcare

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