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Senior Manager, Regulatory Affairs CMC
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Regulatory Affairs Specialist
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Regulatory Affairs
3 months ago
As the healthcare landscape evolves in Hong Kong, we are hiring a RAQA Specialist on a 12 months contract to proactively register our products in Hong Kong. This role is part of a regional team covering Hong Kong and Taiwan markets and will offer you great learning opportunities if you are looking to further develop your career in RAQA.
Subject to business needs, there is an opportunity for contract extension or conversion to a permanent position.
What you will be doing:
Maintain Hong Kong's regulatory affairs (RA) database, including global registration and local tender databases. Provide RA support for quotations and tender exercises. Prepare dossiers and submit license renewals/changes and manage other registration needs according to Company timeline and objectives. Represent the RAQA function as a point of contact for all stakeholders, manage product complaints, commercial hold and field actions in Hong Kong. Other relevant tasks as assigned.Who we are looking for:
Degree in Biomedical Engineering or other Science / Biotech related fields Minimum 1 to 2 years' relevant regulatory affairs experience. Proficiency in Microsoft Word, Excel etc. Excellent communication skills with proficiency in spoken and written English and Chinese. Strong relationship building skills - collaborate well with and able to influence stakeholders. Good track record of meticulous execution of tasks in a timeline driven environment. High ethical standards and integrity. Travel Percentage: 0%