REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

承包商应为NIH蓝图神经治疗网络提供以下咨询支持服务： 监管事务 监管事务顾问将在支持临床前和临床监管事务战略方面发挥领导作用。可能会要求顾问就支持IND的研究和计划提供指导，以确保团队满足IND申请的指导方针和时间表。顾问将作为NIH工作人员、PI、监管机构的主要监管联系人，也可能是食品和药物管理局(FDA)的主要监管代表。 监管事务顾问的作用可包括但不限于以下职责和任务： ·在项目团队内合作，制定监管战略，识别监管风险，并及时获得批准。 ·就与监管战略相关的问题向NIH工作人员和项目团队提供建议；确定与制定监管有关的关切领域。 ·提供关于规范、方法、标准操作规程、协议、报告、标签等的信息，并对其进行审查，以确保合规性。 ·制定和管理监管提交的时间表。 ·独立完成分配的项目。 ·在必要时有效协调CRO和其他顾问在准备监管呈件方面的活动。

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network as follows: Regulatory Affairs Regulatory Affairs consultants will provide leadership in support of regulatory affairs strategies for preclinical and clinical. Consultants may be asked to provide guidance on IND-enabling studies and programs to ensure that teams meet the guidelines and timelines of IND applications. Consultants will serve as the principal regulatory contact with NIH staff, PIs, regulatory agencies, and may also be the primary regulatory representative to the Food and Drug Administration (FDA). The role of the Regulatory Affairs consultant may include but is not limited to the following responsibilities and tasks: • Work within project teams to develop regulatory strategies, identify regulatory risks, and enable timely approval. • Advise NIH staff and project teams on issues related to regulatory strategy; identify areas of concern regarding developing regulations. • Provide input on and review specifications, methods, SOPs, protocols, reports, labeling, etc. for regulatory compliance. • Develop and manage timelines for regulatory submissions. • Work independently to complete assigned projects. • Work effectively to coordinate the activities of CROs and other consultants in the preparation of regulatory submissions as necessary.