Manager – Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the centralized regulatory function for Prolerity Clinical Research's multisite clinical-trial network.

• Oversee regulatory personnel and ensure regulatory readiness from site selection through activation, study maintenance, and closeout.

• Provide active oversight of daily regulatory operations, submissions, document reviews, and resolution of issues.

• Lead regulatory startup processes, establish ownership of studies and timelines, and delineate submission responsibilities.

• Prepare and perform quality checks on regulatory packets, which include Form FDA 1572, investigator agreements, CVs, licenses, training records, financial disclosures, and localized informed consent forms.

• Coordinate sponsor reviews and Central IRB submissions; monitor approvals, outstanding documents, and activation dependencies.

• Collaborate with investigators, site leadership, clinical operations, contracts and budgets, sponsors, CROs, and Central IRBs to overcome startup challenges.

• Confirm approvals, training, documentation, and sponsor authorizations prior to participant consent and the initiation of study activities.

• Manage amendments from submission to implementation, including document distribution, staff training, re-consent, and version retirement.

• Coordinate regulatory requirements for transitions of investigators and changes in study staff.

• Supervise safety submissions, reportable events, continuing reviews, IRB correspondence, study closeout, and record retention.

• Monitor credential and document expirations and secure updates before lapses occur.

• Conduct regulatory quality reviews and assist with monitoring visits, sponsor audits, and FDA inspections.

• Lead corrective and preventive actions in response to regulatory findings.

• Coordinate qualifications, agreements, and regulatory documentation for external laboratories, imaging centers, and outsourced providers.

• Maintain documentation for central laboratories, imaging, and sponsor-vendor interactions.

• Supervise, mentor, and develop regulatory specialists; balance workloads and manage performance effectively.

• Provide onboarding and ongoing training while maintaining 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 enhancements and establish consistent startup and training workflows.

⛳️ Requirements

• Over five years of clinical trial regulatory experience at an investigative site, site network, or site management organization.

• Proven ownership of startup processes for industry-sponsored drug studies.

• At least three years of leadership experience, including staff supervision, coaching, workload management, and accountability for results.

• Practical experience with Central IRB submissions, consent localization, essential regulatory documents, and amendment management.

• Strong understanding of applicable FDA regulations, ICH Good Clinical Practice, and human subject protections.

• Experience in coordinating documentation for laboratories, imaging centers, or other outsourced study procedures.

• Demonstrated ability to develop regulatory processes that are adopted by a team.

• Excellent communication, organizational, and problem-solving skills.

• Capability to manage competing priorities in a remote environment.

• Willingness to travel approximately 20% of the time.

• Familiarity with CRIO, Complion, and other electronic regulatory or investigator site file systems is preferred.

• Experience in supporting medical device studies, a multisite or multistate network, and in sponsor audits or FDA inspections is preferred.

• Bachelor’s degree in a life science or related field, or equivalent relevant experience.

• ACRP or SOCRA certification is preferred.

• RAPS RAC certification is a plus.

🏝️ Benefits

• Fully remote work arrangement.

• Approximately 20% travel to sites across the South, Southeast, and Northeast.

• Opportunities for training and ongoing development.

• Staff coaching and professional development initiatives.

• Leadership responsibilities and ownership of process improvements.