• In addition to items established under ‘Subject Matter Expert (SMEs) General Duties and Responsibilities
• Provide subject matter expertise in regulatory affairs supporting MCM development pathways.
• Strategize innovative regulatory approaches and strategies to MCM development against emerging threats.
• Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges.
• Advise BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities
• At least fifteen (15) years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry; application of master’s degree or higher in biology, microbiology, chemistry, toxicology, or pharmacy with commensurate experience.
• Experience in FDA engagement and development of regulatory documents.

Deliverables would include work products related to the development and management of regulatory affairs strategic planning and guidance within current and planned BARDA vaccine, therapeutic, and/or device/diagnostic advanced development and acquisition contracts