Regulatory Health Scientist

Piper Companies is seeking a Regulatory Health Scientist to join a healthcare company located in Atlanta, GA through a remote position. The Regulatory Health Scientist will focus primarily on delivering advanced scientific, regulatory, and technical expertise to support medical countermeasure (MCM) initiatives, leveraging comprehensive knowledge of FDA regulations governing drugs, vaccines, biologics, and medical devices in the context of public health preparedness and emergency response.

Responsibilities of the Regulatory Health Scientist include:

• Serve as a subject matter expert on FDA regulatory pathways (IND, EUA, IDE, and related mechanisms), providing strategic regulatory guidance for drugs, biologics, and medical devices.
• Lead the development, drafting, review, and lifecycle management of regulatory submissions and amendments for a broad portfolio of medical countermeasures.
• Support and shape regulatory strategy for products within the Strategic National Stockpile (SNS) and CDC-managed assets, ensuring alignment with current FDA guidance and federal policies.
• Conduct in-depth scientific and clinical data reviews to inform regulatory decision-making and support public health emergency preparedness and response efforts.
• Author, edit, and maintain comprehensive regulatory documentation—including protocols, annual reports, amendments, safety reports, and technical memoranda—ensuring compliance with federal requirements, including Section 508 accessibility standards when applicable.
• Collaborate with federal subject matter experts while maintaining current knowledge of evolving regulations, policies, and scientific advancements to strengthen medical countermeasure preparedness and regulatory compliance.

Qualification for the Regulatory Health Scientist include:

•  Advanced degree (master’s or higher) in public health, regulatory science, pharmacy, medicine, nursing, or a related scientific discipline.
• At least one (1) year of experience supporting FDA regulatory activities for medical products.
• Must have or be able to have to public trust clearance
• Proven experience preparing regulatory submissions and providing regulatory support during public health emergency responses.
• Strong analytical abilities with demonstrated expertise in scientific writing and critical thinking.
• Experience working within federal public health or medical countermeasure environments preferred

Compensation for the Regulatory Health Scientist includes:

• Pay Range: Flexible based on experience
• Comprehensive Benefits: Medical, Dental, Vision, 401K, Sick Leave as required by law

This job opens for applications on 02/20/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: regulatory, regulatory health, scientist, regulatory health scientist, healthcare, FDA regulatory pathways, IND (Investigational New Drug), EUA (Emergency Use Authorization), IDE (Investigational Device Exemption), regulatory strategy, regulatory submissions, regulatory amendments, lifecycle management, regulatory compliance, federal regulations, FDA guidance, Section 508 accessibility, medical countermeasures (MCM), drugs, biologics, medical devices, Strategic National Stockpile (SNS), CDC-managed assets, scientific review, clinical data analysis, regulatory decision-making, public health preparedness, emergency response support, scientific writing, technical memoranda, subject matter expert (SME), federal collaboration, cross-functional coordination, policy analysis, regulatory documentation management, public health, regulatory science

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