性别要求：不限性别
Review of regulatory application form against the SOW to ensure accuracy an d compliance Coordinate with other departments for the completeness of documentations / applications Obtain relevant internal authorization for the documents as applicable Close collaboration with the Global Study Manager （GSM） Ｏr the Regional Study Coordinator （RSC） for all regulatory documentations aspects of the protocol. Maintain knowledge of current regulatory documentation requirements an d guidelines, an d communicate with the Global Project Management team of any changes Maintain all records related to the regulatory documentations / applications for the ease of retrieval in case of inspection Responsible for implementing compliance monitoring of regulatory documentation practices an d taking corrective an d preventive actions when needed Ensure a detailed knowledge of the SOW specifications an d a good understanding of how the SOW specifications impact every operational aspect of the clinical trial, in particular those relevant to the regulatory documentations / applications Monitor, an d track the completion of all regulatory documentations / applications support requests assigned. Keep the GSM Ｏr RSC informed of the progress an d follow-up with the GSM Ｏr RSC if it is pending action by the client. Participate in functional meetings （eg. CLFs） an d provide input, keeping processes up to date Ensure compliance with departmental guidelines an d company standards. Comply with CCLS Global Project Management strategy Support a culture of continuous improvement, quality an d productivity Other duties as assigned
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