Director, Clinical Research Regulatory Affairs

Responsibilities

• Oncology Regulatory Strategy and Assessment
• Develop targeted regulatory strategies for oncology programs across early- and late-phase clinical trials
• Conduct regulatory assessments of drug and device trials to determine exemption eligibility and risk levels
• Monitor evolving regulatory requirements and assess impact on ongoing and planned oncology programs
• Implement process improvements to enhance regulatory effectiveness and compliance
• Regulatory Liaison & FDA Interactions
• Serve as primary regulatory liaison with the FDA for submissions, communications, and inquiries
• Coordinate responses to FDA information requests and regulatory submissions
• Participate in FDA meetings including pre-IND and Type B/C meetings
• Provide regulatory guidance to investigators and study teams on requirements, timelines, and compliance
• Institutional Governance & Leadership
• Align regulatory activities with clinical, scientific, manufacturing, and quality stakeholders
• Lead regulatory document management ensuring accuracy, completeness, and audit readiness
• Review institutional policies, SOPs, and training related to FDA-regulated research
• Direct staff development and provide leadership to regulatory affairs team members
• Regulatory Operations & Compliance
• Ensure compliance with FDA regulations (21 CFR 312, 812), ICH guidelines, and GCP requirements
• Support regulatory activities for investigational drugs, biologics, and devices including INDs and IDEs
• Manage multiple complex regulatory projects simultaneously with strong project management discipline
• Maintain high standards of documentation, reporting, and inspection readiness
• Other duties as assigned

Requirements

• Preferred Master's Degree in a life sciences, pharmacy, medicine, or related field
• Extensive experience in oncology regulatory affairs, including IND and IDE submissions, FDA interactions, FDA submissions, and EMA exposure
• Strong project management expertise
• Advanced knowledge of FDA regulations and ICH/GCP guidelines
• A preferred RAC certification
• Demonstrated leadership and communication skills in complex research environments

Qualifications

• Eight years regulatory affairs experience with FDA submissions, and oncology clinical research to include two years lead project management experience
• Demonstrated experience preparing and managing INDs and/or IDEs; familiarity with companion diagnostics and combination products is a plus
• An in-depth knowledge of FDA regulations, FDA submissions, ICH guidelines, and GCP requirements
• Familiarity with EMA submissions
• Completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience
• Completion of both programs can be substituted for a maximum of two years of supervisory or management experience
• Preferred: RAC - Regulatory Affairs Cert