Advanced Decision Vectors, LLC (ADV), established in 2009, provides superior program management, program support, strategic planning, and systems engineering to the Federal and Commercial sectors. Located in Alexandria, Virginia, ADV is a Small Disadvantaged Business (SDB) contractor that has roots established in the Department of Defense and support agencies. At ADV, our company values are Integrity, Distinction, Experience and Achievement.

Advanced Decision Vectors, LLC (ADV) is seeking a Regulatory Affairs Senior Advisor (SME) in regulatory affairs 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.

Deliverables are:

• Provide regulatory expertise for COVID-19 therapeutic and vaccine products.
• 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.

Responsibilities are but not limited to:

• 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

Requirements:

• At least ten (10) to fifteen (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.

ADV employees are required to be fully vaccinated against COVID-19 regardless of the employee's duty location or work arrangement (e.g., telework, remote work, etc.), subject to such exceptions as required by law. If a covered exemption is requested, it must be approved by our government customer and in line with contractual terms and conditions. You will be required to be vaccinated against COVID-19 and submit documentation of proof of vaccination, if selected.

We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability or veteran status.