Regulatory Specialist

ObjectiveHealth

. Coordinate and participate in regulatory research activities for all sites across ObjectiveHealth .

Posted 10/2/2026full-timeRemote • Tennessee • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory research and compliance within clinical settings, including proficiency in GCP, ICH guidelines, and FDA regulations. Capable of managing regulatory documentation and training while ensuring adherence to IRB protocols and sponsor requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceGCP ComplianceIRB Submission PreparationClinical Research Regulations KnowledgeOrganizational Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ResearchGCPICH GuidelinesFDA RegulationsIRB ProcessesDocumentation ManagementClinical ResearchProtocol ComplianceTraining ManagementStudy Start-Up

Soft Skills

Communication SkillsOrganizational SkillsAttention to DetailCollaborationProblem-Solving

Industry Keywords

Clinical ResearchRegulatory ComplianceHIPAA RegulationsSOPsStudy MonitoringAuditsRegulatory InspectionsTraining LogsInformed Consent FormsDelegation of Authority

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Coordinate and participate in regulatory research activities for all sites across ObjectiveHealth
Prepare, review, manage, track, file, and submit study-specific regulatory and training documents
Maintain delegation of authority and training logs, CVs, licenses, training certificates, and physician credentials
Ensure compliance with IRB-approved protocols, sponsor requirements, company SOPs, HIPAA regulations, GCPs, and applicable state and federal laws
Follow up on pending signatures and missing documentation
Collaborate with internal teams, research staff, investigators, and external sponsors to resolve issues
Prepare IRB submissions, including initial protocols, amendments, and safety updates
Review and edit Informed Consent Forms for regulatory and protocol compliance
Participate in study start-up, monitoring visits, audits, and regulatory inspections
Maintain current knowledge of clinical research regulations, GCP, and FDA/ICH guidance
Provide regulatory training to site staff as needed

Requirements

What you’ll need

Bachelor’s degree in life sciences, healthcare, or related field (preferred)
2+ years of experience in clinical research regulatory affairs or a similar role
Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes
Excellent organizational, communication, and documentation skills
Ability to manage multiple priorities and deadlines with strong attention to detail
Legal authorization to work in the US
Not currently accepting work visas

Benefits

Comp & perks

Competitive compensation
401(k) with Company match
A clear career pathway for advancement within the Company
Short- and Long-Term Disability
Health Savings and Flexible Spending Accounts
Health, Dental and Vision insurance Plans
Generous PTO
Adoption Assistance
Paid Holidays
A wide selection of other voluntary benefits