REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

承包商应为帮助戒除成瘾长期 (HEAL) 项目提供如下咨询支持服务： 监管事务 监管事务顾问将提供领导支持临床前和临床的监管事务策略。顾问可能会被要求提供有关 IND 支持的研究和计划的指导，以确保团队符合 IND 申请的指南和时间表。顾问将作为与 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。 监管事务顾问的角色可能包括但不限于以下职责和任务： • 与项目团队合作制定监管策略、识别监管风险并及时获得批准。 • 就与监管策略相关的问题向NIH 工作人员和项目团队提供建议；确定有关制定法规的关注领域。 • 提供规范、方法、SOP、协议、报告、标签等方面的意见并进行审查，以确保法规遵从性。 • 制定和管理监管提交的时间表。 • 独立完成分配的项目。 • 有效协调CRO 和其他顾问在必要时准备监管提交文件的活动。 疼痛;疼痛治疗开发计划；疼痛

The Contractor shall provide consulting support services to Helping End Addiction Long-term (HEAL) projects 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. Pain; Pain Therapy Development Program; Pain