The specific consultant SME technical areas required are outlined below. 1. Ultra-Rare Disease Regulatory Affairs Regulatory Affairs consultants will provide advice and leadership in support of regulatory affairs strategy for preclinical and clinical programs. Consultants will be asked to provide guidance on IND-enabling studies to ensure that teams meet the guidelines and timelines of IND applications. Regulatory Affairs SME Consultants must have: a) Experience with regulatory submissions including preparation of INDs for rare and/or ultrarare diseases including First in Human (FIH) and Phase I clinical trials for biologics such as oligonucleotide therapeutics and/or viral vector-based gene therapy and/or genome editing is preferred b) SME consultants supporting the URGenT program should have at least 5 years of experience in supporting rare/ultra-rare biologics product development programs c) Extensive knowledge and understanding of global regulatory regulations and guidelines. d) Expertise in developing regulatory strategy and gap analysis for biological therapeutics e) Extensive knowledge and understanding of preclinical IND-enabling study requirements and CMC requirements f) Expertise in preparing and reviewing regulatory documents, responding to agency meeting requests g) Experience in accelerated regulatory approval pathways such as Orphan Drug Designation, Fast Track Status or Priority Review is desired h) Proven track record of early recognition of potential regulatory issues especially with IND filings, distilling complex situations, sound risk assessment and overcoming hurdles The roles of the Regulatory Affairs and Regulatory Operations SME consultants may include but are not limited to the following responsibilities and tasks: a) In partnership with other consultants, contractors, and the NIH staff, advise, and strategically plan product development activities to facilitate preclinical evaluation and safety testing, IND submission, and clinical studies b) Provide strategy and feedback on biologics product development and manufacturing plans proposed by the team c) Consultants will provide the type of input that will allow the NINDS to design and implement new programs to address external research needs and objectives. d) Work within project teams to develop regulatory strategies, identify regulatory risks, and enable timely approval e) Advise NIH staff and project teams on issues related to regulatory strategy; identify areas of concern regarding developing regulations f) Provide strategic guidance for the continued development and improvement of the URGenT program