Regulatory Health Scientist

Cherokee Federal•Atlanta, GA

About The Position

Cherokee Nation Integrated Health (CNIH) is seeking a Regulatory Health Scientist to join our team in Atlanta, GA. In this role, you will provide advanced scientific, regulatory, and technical expertise in support of medical countermeasure (MCM) activities, applying in-depth knowledge of FDA regulations governing drugs, vaccines, biologics, and medical devices within the context of public health preparedness and emergency response. The position requires the ability to integrate clinical, scientific, regulatory, and operational considerations to support regulatory mechanisms and ensure the safe, effective, and compliant use of medical products across a range of threat agents and regulatory pathways.

Requirements

This position requires an active NACI clearance or the ability to obtain a NACI clearance to be considered.
As required by our governmental client, this position requires being a U.S. citizen.
Graduate-level degree (Master’s or higher) in public health, regulatory science, pharmacy, medicine, nursing, or related scientific discipline.
Minimum one (1) year of experience supporting FDA regulatory activities related to medical products.
Demonstrated experience with regulatory submissions and emergency response regulatory support.
Strong analytical, scientific writing, and critical thinking skills.
Must pass the pre-employment qualifications of Cherokee Federal.

Nice To Haves

Experience in federal public health or medical countermeasure environments preferred.

Responsibilities

Provide subject matter expertise on FDA regulatory pathways, including IND, EUA, IDE, 510(k), and related mechanisms.
Develop, draft, review, and maintain regulatory submissions and amendments for medical countermeasures.
Support regulatory strategy development for products in the Strategic National Stockpile (SNS) and CDC-managed assets.
Perform scientific and clinical data reviews to support regulatory decision-making.
Prepare and edit regulatory documents, including protocols, annual reports, amendments, safety reports, and technical memoranda.
Provide regulatory support during public health emergency responses.
Collaborate with federal subject matter experts to ensure regulatory compliance and alignment with current FDA guidance.
Ensure regulatory documentation meets federal requirements, including Section 508 accessibility standards when required.
Maintain awareness of evolving FDA policies and regulatory frameworks related to public health preparedness.