REGULATORY AFFAIRS CONSULTING SUPPORT SERVICES

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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.