Senior Regulatory Affairs SME | Healthcare and Life Sciences [HHS123028]
Core
Senior Regulatory Affairs SME providing strategic advisory and subject matter expertise for medical countermeasures (vaccines, therapeutics, diagnostics) against CBRN threats and emerging infectious diseases.
Role type
Senior IC Regulatory Affairs SME (Strategic Advisor)
Builds
Regulatory pathways, submission strategies, and expert assessments for BARDA medical countermeasure programs
Domain
Healthcare and Life Sciences / Biopharmaceuticals / Government Contracting
Required skills
Regulatory affairs strategy, FDA engagement, medical countermeasure development, risk/benefit analysis, regulatory document authoring, program-level advisory
Preferred skills
Medicinal chemistry, preclinical/clinical development, sterile manufacturing, process scale-up, device development, microbiology/virology/immunology
Technologies
None stated
Responsibilities
Advise BARDA senior leadership on regulatory challenges, author regulatory documents, serve on Technical Evaluation Panels, review study protocols and regulatory submissions, strategize regulatory approaches for emerging threats, collaborate on Total Life Cycle Cost efforts
Seniority
Senior, hands-on IC with strategic advisory focus