Overview In this role you will serve as a senior Regulatory Affairs SME supporting BARDA and HHS programs within Healthcare and Life Sciences. You will guide regulatory strategy for medical countermeasures, including vaccines, therapeutics, and diagnostics, and advise federal teams on submissions, regulatory documents, and compliance. You will work across BARDA programs to shape development paths and ensure regulatory readiness. The position offers impact at the intersection of public health, policy, and advanced R&D in a mission-driven environment.
Compensation / Benefits- Competitive compensation
- Group health benefits (medical, dental, vision)
- 401(k) with company match
- PTO and holidays
- FSA/POP pre-tax plans
- Security clearance opportunities
Responsibilities- Support BARDA Program Offices as regulatory SME in threats areas (chemical, radiological, biological, influenza, emerging infectious diseases)
- Provide regulatory guidance on development, licensure/clearance, and manufacturing aspects of MCMs
- Contribute to technical evaluations, market research, and proposal reviews on regulatory topics
- Develop and review regulatory documents, study protocols, and regulatory submissions
- Advise senior BARDA leadership on regulatory strategies and program development
- Support cost estimates, risk analyses, and TLCC considerations for notional programs
- Lead or participate in Program Coordination Teams and Technical Evaluation Panels
- Mentor and educate federal staff on regulatory pathways for MCMs
- Collaborate with FDA and other authorities to ensure regulatory alignment and readiness
- Support strategic discussions for new BARDA program areas and portfolio management
Key requirements- At least 15 years of senior-level regulatory affairs experience
- Significant FDA engagement and regulatory submissions experience
- Master's degree or higher in biology, microbiology, chemistry, toxicology, pharmacy, or related field
- Expertise in regulatory affairs for medical countermeasures (MCMs) including vaccines, therapeutics, and diagnostics
- Strong communication and strategic advisory capabilities
- Knowledge of regulatory guidelines, compliance, and MCM development pathways
- Leadership in addressing program-level regulatory challenges
- Ability to author and review regulatory documents and manage submissions
- Excellent communication
- Strategic advisory capabilities
- Leadership
- Regulatory affairs for MCMs (vaccines, therapeutics, diagnostics)
- FDA processes and compliance
- Regulatory submissions and document management
