FDA Regulatory Expert Needed to Lead Approval Strategy for Patent-Pending Injectable Drug

FDA Regulatory Expert Needed to Develop Regulatory Strategy for Patent-Pending Injectable Therapeutic We are an early-stage company that has developed a novel sterile injectable therapeutic formulation that is currently in the patent application process. We are seeking an experienced FDA regulatory expert (regulatory affairs professional, FDA attorney, or former FDA reviewer) to help us determine the most appropriate regulatory pathway and develop a comprehensive strategy for bringing this product through the FDA approval process. At this stage, we are looking for a long-term regulatory partner rather than someone to prepare a single submission. Our objective is to identify an experienced professional who can guide the program from early regulatory planning through FDA approval. Initial Scope The first phase of the engagement will focus on developing a regulatory roadmap, including: Evaluating the appropriate FDA regulatory pathway. Advising on product classification. Identifying the major regulatory milestones. Advising on preclinical requirements. Providing guidance regarding Chemistry, Manufacturing, and Controls (CMC). Advising on FDA interactions, including whether and when a Pre-IND meeting would be appropriate. Identifying key regulatory risks and recommended next steps. If the initial engagement is successful, we anticipate expanding the relationship into subsequent phases of development. Because the formulation contains proprietary intellectual property and is currently patent pending, technical details will be shared only with selected candidates. Ideal Experience We are particularly interested in professionals with experience in: FDA drug development Sterile injectable products IND strategy and submissions NDA or other FDA marketing application pathways CMC strategy Clinical development cGMP Early-stage biotechnology or pharmaceutical companies Former FDA reviewers, senior Regulatory Affairs professionals, and FDA regulatory attorneys are encouraged to apply. Please Include in Your Proposal A summary of your experience with FDA-regulated pharmaceutical products. Examples of similar projects you have worked on. How you would approach the initial regulatory strategy phase. An estimate of the expected scope, timeline, and cost for the initial strategy phase. How you typically structure longer-term regulatory engagements. We are looking for a knowledgeable, collaborative expert who can become a trusted long-term advisor as we advance this program.