Regulatory Affairs and FDA Submission Support

The contract requires expert leadership in regulatory affairs focused on FDA submissions for biologics and pharmaceutical products, with primary responsibilities including the development and preparation of Investigational New Drug and Biologics License Application documents, with special emphasis on Chemistry, Manufacturing, and Controls sections. The role involves coordinating and supporting interactions with the FDA through preparatory work for agency meetings, ensuring all regulatory documentation meets current standards and guidelines. The work is critical to advancing product development through the regulatory pathway and requires deep technical knowledge of FDA expectations and global regulatory frameworks. This subcontract is posted under the North American Industry Classification System code 541618 and is managed by the Army Medical Resources Acquisition Activity within the Department of Defense. Performance is required in Frederick, Maryland, with a response deadline of May 4, 2026, at 7:00 PM. Although no set-aside designation is specified, the opportunity is targeted toward qualified subcontractors with demonstrated experience in oncology, immunology, or advanced biologic therapies, and the ability to work within federal compliance frameworks supporting Defense Health Program initiatives.