This is for consulting services for Senior Staff.

非临床开发顾问将为NIH生物制品项目的监管批准的产品开发全过程提供支持。将要求顾问就促进可持续发展的研究提供指导，以确保团队符合可持续发展申请的指导方针和时间表。顾问将作为NIH工作人员、PI和监管机构的主要监管联系人，也可能是FDA的主要监管代表。

Non-Clinical Development consultants will provide leadership in support of the full process of product development for regulatory approval for NIH biologics programs. Consultants will be asked to provide guidance on IND-enabling studies to ensure that teams meet the guidelines and timelines of IND applications. Consultants will serve as the principal regulatory contact with NIH staff, PIs, and regulatory agencies, and may also be the primary regulatory representative to the FDA.