Steve Sibley 在制药行业拥有逾 30 年经验，目前为 Certara 药物开发解决方案（CDDS）提供法规撰写咨询服务，并领导全球申报服务线。He has led global submission teams and authored critical documentation on more than 45 marketing applications and more than 30 investigational drug applications. Sibley has particular expertise in briefing documents, regulatory defense, and submission planning. Sibley’s work has covered the full range of therapeutic areas and program types, with a particularly strong background in oncology, cardiology, and rare diseases, including participation in health authority meetings and advisory committee meetings. His experience is truly global, having worked in project teams encompassing the United States, the European Union, Australia, and Asia. Sibley draws on his substantial industry knowledge and leadership skills to mentor and train other submission leads.