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Assistant Regulatory Intelligence Jobs (NOW HIRING)

Brenntag

QSHE Coordinator

Toledo, OH

The QSHE Specialist will assist with the daily operations and strategic development of the QSHE ... Regulatory Intelligence and Product Compliance * Track and communicate relevant regulatory changes.

Brenntag AG

QSHE Specialist

Toledo, OH · On-site

The QSHE Specialist will assist with the daily operations and strategic development of the QSHE ... Regulatory Intelligence and Product Compliance * Track and communicate relevant regulatory changes.

Xcelerate Solutions

Track and trend FDA regulatory intelligence * Assist with full lifecycle project management and oversight of all projects, to include: * Review/provide input into lifecycle management plans to ensure ...

Fluor

Senior Manager - Customs Compliance

Houston, TX

... to regulatory intelligence and continuous improvement initiatives. The position works closely with ... Broker Assist with customs broker performance monitoring, issue resolution, and escalation as ...

Noah Medical

Sr. RA Specialist

San Jose, CA · Hybrid

Provide regulatory subject matter expertise during audits and inspections. * Assist in developing ... Regulatory Intelligence * Monitor industry trends, regulatory changes, guidance documents, and ...

U.S. Venture, Inc.

Senior Data Engineer - IGEN

Appleton, WI · On-site

$103K - $140K/yr

Uses AI development assistants - GitHub Copilot, Microsoft Copilot, Claude, and emerging agent ... Designs and operates the regulatory intelligence pipeline - ingesting jurisdictional updates from ...

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As of Jul 16, 2026, the average hourly pay for assistant regulatory intelligence in the United States is $34.60, according to ZipRecruiter salary data. Most workers in this role earn between $22.36 and $26.20 per hour, depending on experience, location, and employer.
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Infographic showing various Assistant Regulatory Intelligence job openings in the United States as of July 2026, with employment types broken down into 1% As Needed, 75% Full Time, 21% Part Time, 1% Temporary, and 2% Contract. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $71,960 per year, or $34.6 per hour.
Senior Regulatory Affairs Scientist

Senior Regulatory Affairs Scientist

CICONIX, LLC

Fort Detrick, MD

Full-time

Medical, Retirement, PTO

Re-posted 24 days ago

Job description

Senior Regulatory Affairs Scientist
About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact. 
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Location(s): Fort Detrick, MD
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Position Details:
  • Full-time position
  • Regular weekly hours (0900-1600)
  • No calls, nights, weekends, or holidays!
  • Full benefit program, including: health, PTO, & 401k + contribution
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Requirements:
  • Possess a Regulatory Affairs Certification (RAC).
 
 
Summary:
CICONIX is seeking a Senior Regulatory Affairs Scientist to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD.
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About the Role:
  • Ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions. Regulatory Affairs support includes but is not limited to the following:
    • Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports.
    • Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team on any FDA-related activities and issues, and attending meetings, updating ORA leadership and the sponsor’s representative through routine reports.
    • Lead the development of a written regulatory strategy and provide to the Government The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
    • Create or provide input to and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
    • Identify and mitigate regulatory risk through a project Risk Register.
    • Serve as the primary contact with the FDA for assigned products; review, analyze, and respond to FDA communications and meetings by the regulatory deadline and maintain meeting minutes in EDMS.
    • Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS.
    • Participate and represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility as requested.
    • Provide regulatory assistance for Quality Management System assessments done at the manufacturing facility performed by ORA or external consultants.
    • Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities.
    • Enter information in ClinicalTrials.gov for clinical studies prior to study initiation. Provide quality assurance for the data and information entered, and ensure compliance with the current regulatory, DHA, and ORA requirements to include upload of required documents, record verification at least once every 6 months, and updates within 30 days for changes to recruitment status, sponsor IRB, approval etc. Enter clinical study results NLT 12 months after the study’s primary completion date.
    • Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents.
    • Train, and develop regulatory staff, managing workloads and ensuring alignment with project and program objectives.
    • Lead and/or actively participate in working groups for ORA process improvement, continued learning, regulatory intelligence, and quality review.
    • Write, review, and/or revise SOPs.
    • Provide subject matter expertise on all FDA regulatory matters related to assigned regulatory projects; monitor emerging regulations (United States and global), trends, and agency expectations to assess impact and advise ORA leadership and the sponsor’s representative.
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Qualifications:
  • Education:
    • TBD
  • Licensure & Certifications (Current & Unrestricted): 
    • Possess a Regulatory Affairs Certification (RAC).
  • Experience: 
    • TBD
  • Security & Background Check: 
    • U.S. Citizenship and a successful background investigation are required.
    • Ability to obtain and maintain a government security clearance. 
  • Additional Requirements:
    • Willingness to comply with the government vaccination requirements.
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Compensation: TBD
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*This position is contingent and will begin upon contract award.
CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.
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