A Subject Matter Expert in Regulatory Affairs is needed to provide advisory support to the Biomedical Advanced Research and Development Authority (BARDA), within the U.S. Department of Health and Human Services in Washington, DC. The mission of BARDA is to develop and procure medical countermeasures (MCM) that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. For more information on BARDA please visit their website at: http://www.phe.gov/about/BARDA/Pages/default.aspx

Major Duties & Responsibilities:

• Provide advisory subject matter expertise and in regulatory affairs supporting MCM development pathways
• Strategize innovative regulatory approaches to MCM development against emerging threats
• Advise regulatory and BARDA senior leadership on critical programmatic and project level regulatory challenges
• Provide training and advisement to BARDA staff on regulations, authoring regulatory documents, and interactions with regulatory authorities

Deliverables:

Provide regulatory expertise for COVID-19 therapeutic and vaccine products. 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, device/diagnostic, and/or antimicrobial advanced development and acquisition contracts.

Requirements:

• At least 10 - 15 years of relevant industry experience at senior regulatory affairs positions in the pharmaceutical industry.
• Application of doctoral degree in biology, chemistry, or pharmacy with commensurate experience.

Please be advised that Tunnell employees are required to be fully vaccinated against COVID-19 as per CDC guidelines and subject to legal requirements. In accordance with Tunnell’s COVID-19 Vaccination Policy, employees need to confirm that they are fully vaccinated or engage in an interactive dialogue with Human Resources to determine eligibility for a religious or medical exception, and whether making such an exception would pose an undue burden or undue risk of harm. Additionally, client-facing employees are also expected to comply with all current and future client requirements for COVID-19 safety, including but not limited to surveillance testing, masking requirements, social distancing, and any other requirements.