Program Management and Regulatory Affairs

The contract entails comprehensive program management and regulatory affairs support for a drug-device combination product, focusing on end-to-end oversight of critical development and compliance activities. This includes managing regulatory submissions to health authorities, conducting human factors studies to ensure safe and effective user interaction, validating process performance qualification (PPQ) batches to confirm manufacturing consistency, and fulfilling all post-market licensing commitments required by regulatory agencies. The scope demands deep expertise in both pharmaceutical and medical device regulations, with an integrated approach to aligning clinical, quality, and technical documentation across global standards. The work is governed under a subcontract agreement linked to the Department of Health and Human Services via Barda - Aspr / Daappo / Barda Dcma, with performance centered in Washington, DC, at ZIP code 20024. The solicitation was posted on July 2, 2026, and responses are due by July 30, 2026, under the NAICS code 541611 for management consulting services. The contractor is expected to deliver coordinated, high-quality regulatory strategy and execution in a tightly regulated environment, ensuring timely approvals and sustained compliance throughout the product lifecycle.