Regulatory Affairs and FDA BLA Submission Management

The contract mandates end-to-end management of Biologics License Application submissions for influenza vaccines, with a primary focus on coordination with the FDA, timely and comprehensive responses to regulatory queries, and ongoing lifecycle management to ensure compliance and continuity. The role requires deep regulatory expertise to navigate the complexities of BLA preparation, submission, and post-submission interactions with federal authorities, ensuring all documentation and scientific data meet stringent regulatory standards. The work is scoped under a subcontract for the Department of Health and Human Services, specifically managed by Barda-ASPR, with performance concentrated in Washington, DC, at the 20024 zip code. The solicitation was posted on July 30, 2026, and responses are due by August 15, 2026, with the North American Industry Classification System code 541611 indicating specialized regulatory affairs and scientific consulting services. The position demands a high level of precision, regulatory fluency, and the ability to operate within strict federal timelines and communication protocols.