Compiling and submitting in a timely manner, all regulatory documents on behalf of Baxter Company Limited in line with regulatory requirements. Respond to any regulatory queries within strictly provided deadlines. Maintain regulatory files in a format consistent with company and SFDA requirements. Manage all regulatory requirements relating to the specific portfolio of company products.
Reviewing and approving labeling and SOPs.
Support Pharmacovigilance activities on behalf of the company and maintain effective communication with the SFDA throughout this process.
Manage the medical device registration process on behalf of the company with the SFDA. Provide a medical device problem and recall reporting system to the SFDA – Medical device department.
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