Regulatory Specialist

Prolerity Clinical Research

Regulatory Specialist coordinating and maintaining regulatory documentation and compliance for clinical trials. Collaborating with regulatory managers, clinical teams, and sponsors on submissions and audits.

Posted 7/29/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory document preparation and submission, ensuring compliance with ICH-GCP and FDA regulations. Proficient in maintaining regulatory files and facilitating communication among research staff, sponsors, and IRBs.

Highest-signal resume keywords

Regulatory Document PreparationICH-GCP ComplianceClinical Research ExperienceStrong Communication SkillsOrganizational Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsInvestigator Site Files ManagementDocument ComplianceAudit PreparationRegulatory Tracking

Soft Skills

Attention to DetailTime ManagementPrioritization

Industry Keywords

FDA RegulationsClinical ResearchRegulatory AffairsSponsor AuditsMonitoring Visits

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Assist in preparing and submitting regulatory documents to IRBs, sponsors, and internal stakeholders including initial submissions, amendments, continuing reviews, and safety reports
Maintain and update Investigator Site Files (ISFs), regulatory binders, and electronic systems to ensure documents are current and properly filed
Help coordinate collection and submission of start-up documents such as site questionnaires, training logs, CVs, and delegation logs
Ensure documentation complies with ICH-GCP, FDA regulations, and sponsor-specific requirements
Serve as a liaison between research staff, investigators, sponsors, and IRBs to facilitate timely and accurate regulatory processes
Keep regulatory files audit-ready and assist with preparation and support during monitoring visits, sponsor audits, or inspections
Attend regulatory meetings, take minutes as needed, and provide updates on document status and submission timelines
Track expiration dates for approvals, licenses, and other time-sensitive documents; assist with regulatory logs and tracking tools

Requirements

What you’ll need

Bachelor’s degree preferred, ideally in life sciences, healthcare, or a related field
At least 1–3 years of experience in clinical research or regulatory affairs
Excellent organizational skills and attention to detail
Ability to manage multiple deadlines and prioritize tasks
Strong written and verbal communication skills

Benefits

Comp & perks

Professionalism when interacting with internal and external stakeholders
Proficiency in Microsoft Office Suite and regulatory document platforms (e.g., CRIO, Complion, Veeva)