Manager – Regulatory Affairs

Prolerity Clinical Research

. Lead the centralized regulatory function for Prolerity Clinical Research’s multisite clinical-trial network .

Posted 10/16/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive regulatory expertise in managing clinical trial processes, including oversight of Central IRB submissions, regulatory document preparation, and compliance with FDA and ICH standards. Proven ability to lead teams, implement process improvements, and ensure regulatory readiness throughout the study lifecycle.

Highest-signal resume keywords

Regulatory ExperienceLeadership ExperienceCentral IRB SubmissionsFDA Requirements KnowledgeRegulatory Process Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Document PreparationAmendment ManagementStudy Closeout ProceduresSafety SubmissionsQuality ReviewsDocument TrackingCompliance Trends ReportingStudy Activation ManagementConsent LocalizationRegulatory Issue Resolution

Soft Skills

Strong Communication SkillsOrganizational SkillsProblem-Solving SkillsWorkload ManagementTeam Development

Tools & Technologies

CRIOComplionElectronic Regulatory SystemsInvestigator Site File Systems

Certifications & Qualifications

ACRP CertificationSOCRA CertificationRAPS RAC Certification

Industry Keywords

Clinical TrialsFDA InspectionsICH Good Clinical PracticeHuman Subject ProtectionsMultisite Clinical ResearchSponsor AuditsSite Management OrganizationInvestigative SiteRegulatory ReadinessStudy Ownership

About the role

Key responsibilities & impact

Lead the centralized regulatory function for Prolerity Clinical Research’s multisite clinical-trial network
Manage regulatory staff and own regulatory readiness from site selection through activation, study maintenance, and closeout
Provide hands-on oversight of daily regulatory work, submissions, document review, and issue resolution
Lead regulatory startup, establish study ownership and timelines, and define submission responsibilities
Prepare and quality-check regulatory packets, including Form FDA 1572 or investigator agreements, CVs, licenses, training records, financial disclosures, and localized informed consent forms
Coordinate sponsor review and Central IRB submissions; track approvals, outstanding documents, and activation dependencies
Partner with investigators, site leadership, clinical operations, contracts and budgets, sponsors, CROs, and Central IRBs to resolve startup barriers
Verify approvals, training, documentation, and sponsor authorization before participant consent and study activities begin
Manage amendments through submission and implementation, including document distribution, staff training, re-consent, and version retirement
Coordinate regulatory requirements for investigator transitions and study staff changes
Oversee safety submissions, reportable events, continuing reviews, IRB correspondence, study closeout, and record retention
Track credential and document expirations and obtain updates before lapse
Conduct regulatory quality reviews and support monitoring visits, sponsor audits, and FDA inspections
Lead corrective and preventive actions for regulatory findings
Coordinate qualification, agreements, and regulatory documentation for external laboratories, imaging centers, and outsourced providers
Maintain central laboratory, imaging, and sponsor-vendor documentation
Supervise, coach, and develop regulatory specialists; balance workloads and manage performance
Provide onboarding and continuing training and maintain SOPs, templates, checklists, and sponsor-specific guidance
Oversee regulatory communications, study trackers, and electronic regulatory systems
Report cycle times, blocked items, document completeness, and compliance trends to leadership
Implement measurable process improvements and establish consistent startup and training workflows

Requirements

What you’ll need

More than five years of site-side clinical trial regulatory experience at an investigative site, site network, or site management organization
Startup ownership for industry-sponsored drug studies
At least three years of leadership experience, including staff supervision, coaching, workload management, and accountability for results
Hands-on experience with Central IRB submissions, consent localization, essential regulatory documents, and amendment management
Strong working knowledge of applicable FDA requirements, ICH Good Clinical Practice, and human subject protections
Experience coordinating documentation for laboratories, imaging centers, or other outsourced study procedures
Experience developing regulatory processes adopted by a team
Strong communication, organizational, and problem-solving skills
Ability to manage competing priorities remotely
Ability to travel approximately 20%
Experience with CRIO, Complion, and other electronic regulatory or investigator site file systems preferred
Experience supporting medical device studies, a multisite or multistate network, and sponsor audits or FDA inspections preferred
Bachelor’s degree in a life science or related field, or equivalent relevant experience
ACRP or SOCRA certification preferred
RAPS RAC certification is a plus

Benefits

Comp & perks

Fully remote work arrangement
Approximately 20% travel to sites across the South, Southeast, and Northeast
Training and continuing development opportunities
Staff coaching and professional development
Leadership responsibility and process improvement ownership