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Fda Regulatory Project Manager Jobs (NOW HIRING)

Tufts Medicine

Regulatory Coordinator

Boston, MA · On-site

Job Profile Summary This role focuses on managing operational aspects of ongoing projects from ... to FDA Good Clinical Practice (GCP) guidelines. Physical Requirements: 1. This is largely a ...

Tufts Medicine

Job Profile Summary This role focuses on managing operational aspects of ongoing projects from ... to FDA Good Clinical Practice (GCP) guidelines. Physical Requirements: 1. This is largely a ...

IMMY

Regulatory Affairs Specialist - FDA

Norman, OK · Remote

Manage Q-Submissions and other formal interactions with FDA review divisions, including tracking ... S. regulatory status of the marketed portfolio on an ongoing basis to confirm that each product ...

Ora

Regulatory Writer I

... FDA from pre-clinical to clinical trials Phase 1 - 4. This is an individual contributor working on a team as an active partner in regulatory project planning and execution reporting to the Manager of ...

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Fda Regulatory Project Manager information

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How much do fda regulatory project manager jobs pay per year?

As of Sep 11, 2026, the average yearly pay for fda regulatory project manager in the United States is $110,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,500.00 and $136,500.00 per year, depending on experience, location, and employer.

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For Fda Regulatory Project Manager jobs, the most frequently searched job titles are:

Infographic showing various Fda Regulatory Project Manager job openings in the United States as of September 2026, with employment types broken down into 86% Full Time, 13% Part Time, and 1% Contract. Highlights an 86% Physical, 2% Hybrid, and 12% Remote job distribution, with an average salary of $110,733 per year, or $53.2 per hour.

Senior Regulatory Affairs Scientist

Fort Detrick, MD • On-site

CICONIX, LLC
Business Management Consulting • 11 - 50 employees
Learn more about CICONIX, LLCexternal

Full-time

Medical, Retirement, PTO

Re-posted 21 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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