Regulatory Health Scientist

Job Summary

A company is looking for a Regulatory Health Scientist to provide scientific, regulatory, and technical expertise in support of medical countermeasure initiatives.

Key Responsibilities

• Serve as a subject matter expert on FDA regulatory pathways, providing strategic guidance for drugs, biologics, and medical devices
• Lead the development and lifecycle management of regulatory submissions and amendments for medical countermeasures
• Conduct scientific and clinical data reviews to inform regulatory decision-making and support public health emergency preparedness

Required Qualifications

• Advanced degree (master's or higher) in public health, regulatory science, pharmacy, medicine, nursing, or a related discipline
• At least one year of experience supporting FDA regulatory activities for medical products
• Must have or be able to obtain public trust clearance
• Proven experience preparing regulatory submissions for public health emergency responses
• Experience working within federal public health or medical countermeasure environments preferred