Regulatory Health Scientist

***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.

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.

Compensation & Benefits:

Pay commensurate with experience.

Full-time benefits include Medical, Dental, Vision, 401K and other possible benefits as provided. Benefits are subject to change with or without notice.

Regulatory Health Scientist Responsibilities Include:

• 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.

Regulatory Health Scientist Experience, Education, Skills, Abilities requested:

• 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.
• Experience in federal public health or medical countermeasure environments preferred.

• Must pass the pre-employment qualifications of Cherokee Federal.

Company Information:

Cherokee Nation Integrated Health (CNIH) is a part of Cherokee Federal - the division of tribally owned federal contracting companies owned by Cherokee Nation Businesses. As a trusted partner for more than 60 federal clients, Cherokee Federal LLCs are focused on building a brighter future, solving complex challenges, and serving the government's mission with compassion and heart. To learn more about CNIH, visit cherokee-federal.com.

#CherokeeFederal #LI-SH1 #LI-REMOTE

Cherokee Federal is a military-friendly employer. Veterans and active military transitioning to civilian status are encouraged to apply.

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Keywords

• Regulatory Compliance

• Health Regulations

• Scientific Evaluation

• Policy Analysis

• Pharmaceutical Compliance

Legal Disclaimer: All qualified applicants will receive consideration for employment without regard to protected veteran status, disability or any other status protected under applicable federal, state or local law.
Many of our job openings require access to government buildings or military installations. Candidates must pass pre-employment qualifications of Cherokee Federal.