Director of Regulatory Affairs - REMOTE

Job Description

Job Description

Job Description: Director of Regulatory Affairs

Location: Remote (U.S.-Based) - Any Location

Employment Type: Full-Time

Position Summary

We are seeking an experienced and detail-oriented Director of Regulatory Affairs to lead regulatory operations supporting clinical research activities. This role will oversee a team of Clinical Research Coordinators (CRCs) and regulatory staff while ensuring compliance with federal regulations, sponsor requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.

The Regulatory Affairs Supervisor will serve as a key liaison between investigators, sponsors, contract research organizations (CROs), and regulatory agencies to support the successful execution of clinical trials from study startup through closeout.

Key Responsibilities

Regulatory Leadership & Oversight

• Supervise and mentor regulatory coordinators and Clinical Research Coordinators (CRCs).
• Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional policies.
• Oversee preparation, submission, and maintenance of regulatory documents for clinical trials.
• Manage regulatory activities throughout the study lifecycle, including startup, amendments, continuing reviews, reportable events, and study closeout.
• Maintain regulatory binders, essential documents, and study files to ensure audit readiness.

Clinical Trial Management Support

• Collaborate with Principal Investigators, study teams, sponsors, and CROs to facilitate regulatory compliance and study execution.
• Review study protocols, informed consent documents, investigator brochures, and sponsor communications.
• Support site initiation, monitoring, audit, and closeout activities.
• Track regulatory milestones and ensure timely submissions and approvals.

Team Supervision

• Provide leadership, training, onboarding, and performance management for CRCs and regulatory personnel.
• Establish workload priorities and ensure timely completion of regulatory deliverables.
• Develop standard operating procedures (SOPs) and best practices to improve operational efficiency.
• Foster a culture of quality, accountability, and continuous improvement.

Quality & Compliance

• Conduct internal audits and quality reviews of study documentation.
• Identify compliance risks and implement corrective and preventive actions (CAPAs).
• Serve as a regulatory subject matter expert during sponsor audits, FDA inspections, and institutional reviews.
• Monitor regulatory changes and communicate updates to research staff.

Required Qualifications

• Bachelor's degree in Life Sciences, Healthcare Administration, Public Health, Nursing, Pharmacy, or related field.
• 5+ years of experience supporting clinical research and regulatory affairs.
• 2+ years of supervisory or team leadership experience.
• Strong knowledge of:
• FDA regulations
• ICH-GCP guidelines
• Human Subjects Protection requirements
• IRB processes
• Clinical trial operations
• Experience managing regulatory submissions for multiple clinical studies.
• Excellent organizational, communication, and project management skills.

Preferred Qualifications

• Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent certification.
• Experience with oncology, device, pharmaceutical, or multisite clinical trials.
• Familiarity with CTMS, eRegulatory systems, and electronic document management platforms.
• Experience supporting FDA inspections and sponsor audits.

Benefits

• Fully remote work environment
• Competitive salary
• Medical, dental, and vision insurance
• Paid time off and holidays
• 401(k) with company match
• Professional development opportunities
• Career growth within a collaborative research organization

Ideal Candidate:

The ideal candidate is a proactive regulatory professional with strong clinical research experience who enjoys leading teams, ensuring compliance, and supporting high-quality clinical trial execution in a fast-paced remote environment.