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·To develop and maintain the product portfolio of the company;

·To establishes, implements, and directs the application of policies, procedures, and operating processes in compliance with all appropriate laws, regulations, policies, and conventions.

·To make regulatory strategy, including analysis of products from a regulatory point of view and implementation of procedures required to put them on market;

·Set up, submission and follow up of files required for pharmaceutical marketing Authorization, medical device or cosmetic license;

·Follow up of product variations (manufacturing site change, Active ingredient or finished product specification change…): adapt the core variation dossier to Chinese regulation, submission, achievement and implementation of the variation to packaging components (leaflet, carton, strip, tube) if needed;

·Make product license renewal activities;

·Review all promotional operations (consulting, documents, public relations, etc.) and ensure to comply with CFDA requirements;

·Establish and consolidate the relationship with internal and external key stakeholders;

·Regular communication with global team, clearly deliver CFDA requests for registration the products;

·Take part in the preparation of internal operating procedures of the operating site, and following company SOP for regulatory documentation archiving;

·Insight on policy changes, to assess the impact of the company business and make proper strategy adjustment proposal from Regulatory view;

·Drawing up of reports relating to legislation affecting medical devices, especially for HA fillers;

·Take part in the preparation of the operating site inspections and good pharmacovigilance practices.

·BA degree in Medical or pharmcy or a combination of education and experience providing equivalent knowledge or above.

·Minimum of 8 or above years' experience in Regulatory Affairs;

·Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with global/local project team personnel;

·Demonstrated ability in project management skills in order to plan, conduct and implement regulatory submissions;

·Skill in determining alternatives that would correct a situation to comply with standards and regulations;

·Well established good relationship in CFDA,CMDE, NIFDC and some medical device type test institutes;

·Well communication skill both in Chinese and English.

·Achievement

·Customer and Brand Focus

·Impact and Influence

·Cooperation

·Courage and integrity

·Initiative and Anticipation

·Innovation

·Implementation 

联系人：Hailey Chen

联系方式：15371491509（微信同号）

邮箱：hailey.chen@isaac-kenneth.com