Manager of Regulatory Affairs

Job Description

Job Description

Description:

Remote | Approximately 20% travel to sites across the South, Southeast, and Northeast

Position Overview

The Manager of Regulatory Affairs leads the centralized regulatory function for Prolerity Clinical Research, a multisite network conducting industry-sponsored clinical trials, primarily investigational drug studies with some medical device studies. This role manages regulatory staff and owns regulatory readiness from site selection through activation, ongoing study maintenance, and closeout. This is a hands-on leadership role requiring active oversight of daily regulatory work and direct support with submissions, document review, and issue resolution as needed to meet study milestones.

The Manager partners with principal investigators, site leadership, clinical operations, contracts and budgets, sponsors, CROs, and Central IRBs to coordinate study startup, resolve barriers, and maintain complete, accurate, inspection-ready records. This remote role requires approximately 20% site travel for training, operational support, quality reviews, and inspection preparation.

Study Startup and Activation

• Lead regulatory startup across the network, establishing study ownership, timelines, submission responsibilities, and sponsor-specific requirements at kickoff.
• Prepare and quality-check regulatory packets, including Form FDA 1572 or investigator agreements as applicable, CVs, licenses, training records, financial disclosures, and localized informed consent forms.
• Coordinate sponsor review and Central IRB submissions according to study requirements; track approvals, outstanding documents, and activation dependencies.
• Partner with contracts, budgets, and site operations to align consent language with agreed study terms and resolve startup barriers promptly.
• Verify required approvals, training, documentation, and sponsor authorization are in place before participant consent and study activities begin. Escalate readiness gaps and coordinate appropriate holds with investigators and leadership.

Regulatory Maintenance and Inspection Readiness

• Manage amendments from submission through implementation, including approved document distribution, documented staff training, re-consent when required, and retirement of superseded versions.
• Coordinate regulatory requirements for investigator transitions and study staff changes, including applicable sponsor and IRB notifications or approvals, training documentation, delegation records, and updates to study documents
• Oversee timely safety submissions, reportable events, continuing reviews when required, IRB correspondence, study closeout, and record retention.
• Track credential and document expirations, including licenses, training, laboratory certifications, and reference ranges; obtain updates before they lapse.
• Conduct routine regulatory quality reviews, support monitoring visits, sponsor audits, and FDA inspections, and lead corrective and preventive actions for regulatory findings.

Laboratory and Vendor Documentation

• Coordinate with site operations, investigators, sponsors, and contracting teams to ensure external laboratories, imaging centers, and other outsourced providers have applicable qualifications, agreements, and regulatory documentation in place.
• Ensure external facilities are reflected in study documents and Form FDA 1572 when applicable, and required access to study records is addressed.
• Maintain central laboratory, imaging, and sponsor-vendor documentation, and coordinate with clinical teams to support required investigator review of results and reports.

Team Leadership and Process Improvement

• Supervise, coach, and develop regulatory specialists; establish clear study ownership, balance workloads, and manage performance across the portfolio.
• Provide onboarding and continuing training, and maintain standardized SOPs, templates, checklists, and sponsor-specific guidance.
• Oversee shared regulatory communications, study trackers, and electronic regulatory systems to support consistent filing, version control, and timely follow-up.
• Report startup cycle times, blocked items, document completeness, and compliance trends to leadership; escalate cross-functional barriers and implement measurable improvements.

Success in This Role

Within the first 90 days, establish clear ownership and tracking for active and startup studies, baseline key cycle times, assess documentation gaps, and implement a consistent startup and training workflow. Ongoing success includes more predictable activation timelines, timely amendment implementation, current credentials, inspection-ready files, and a well-supported regulatory team.

Requirements:

Required Qualifications

• More than five years of site-side clinical trial regulatory experience at an investigative site, site network, or site management organization, including 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, and developing regulatory processes adopted by a team.
• Strong communication, organizational, and problem-solving skills; ability to manage competing priorities remotely and travel approximately 20%.

Preferred Qualifications

• Experience with CRIO, Complion, and other electronic regulatory or investigator site file systems.
• Experience supporting medical device studies, a multisite or multistate network, and sponsor audits or FDA inspections.
• Bachelor’s degree in a life science or related field, or equivalent relevant experience; ACRP or SOCRA certification. RAPS RAC certification is a plus.