Liaise with the local Health Authority on matters pertaining to regulatory activities, licenses and permits for new and existing products.
Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
Review technical dossier of new products and prepare additional documents where necessary.
In-charge with the timely approval and renewal of product licences, company licenses, pre- and post-approval variations, permits and other applications.
Provide appropriate solutions for compliance issues.
Review and approve advertising and promotional items to ensure regulatory compliance.
JOB REQUIREMENTS
Degree qualification in life science related fields.
Minimum 3 years' experience in Regulatory Affairs, experienced in registering health products, food supplement or chinese medicine will be added advantage.
Ability to maintain confidentiality of sensitive areas.
Ability to work independently, good communication and interpersonal skills.
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