Director of Central Regulatory

About the role

As the Director of Central Regulatory, you will lead, oversee, and ensure the delivery of high-quality, compliant, and timely regulatory outcomes across the portfolio. This role involves providing strategic direction and hands-on operational leadership, driving execution through clear governance, risk management, and accountability frameworks.

Responsibilities

• Evaluate, align, and optimize ongoing regulatory processes
• Partner closely with cross-functional Site Support Operations teams and the broader Site Management Organization, as well as site research teams and investigators
• Ensure cross-functional coordination to enable efficient, scalable, and inspection-ready execution that meets or exceeds organizational, regulatory, and sponsor expectations
• Establish and maintain regulatory compliance and quality standards, ensuring inspection readiness for audits, inspections, and sponsor oversight
• Oversee CAPA, non-compliance investigations, and issue resolution, ensuring timely, accurate, and defensible outcomes
• Proactively identify, assess, and mitigate regulatory and operational risks, with clear escalation to leadership as needed
• Ensure adherence to GCP, IRB requirements, internal SOPs, and regulatory guidelines, including development and continuous improvement of SOPs and working practices
• Provide oversight and direction for study startup and ongoing regulatory maintenance activities, ensuring alignment with timelines and sponsor expectations
• Maintain visibility to portfolio-level performance, priorities, and execution risks, and take action to mitigate delays
• Create and sustain a decision-driven operating model, with clear ownership, escalation pathways, and traceability across all levels of the organization
• Establish and track departmental goals, KPIs, and performance metrics, ensuring alignment with organizational objectives
• Provide regular, transparent communication to executive leadership on risks, progress, and performance
• Ensure issues are escalated appropriately and resolved within defined timelines
• Partner closely with Site Support Operations, study teams, and Site Management Organization stakeholders to drive aligned, efficient regulatory processes
• Collaborate with sites, investigators, sponsors, CROs, and IRBs to ensure quality delivery and strong working relationships
• Engage with site leadership to ensure contracted regulatory services are delivered effectively and consistently
• Represent the organization’s regulatory strategy, standards, and expectations to internal and external stakeholders
• Lead, develop, and optimize the regulatory organization by driving performance accountability, aligning resources to priority work and risk areas, and building leadership capability and bench strength
• Foster a collaborative, high-performance culture focused on ownership, quality, and continuous improvement
• Develop and implement strategies to support recruitment, retention, and professional development
• Evaluate and optimize regulatory processes to improve efficiency, standardization, and scalability
• Identify and eliminate process inefficiencies and workflow gaps impacting delivery
• Contribute to development and execution of organizational and departmental strategies
• Provide proactive, data-driven recommendations to improve performance and mitigate risk
• Align regulatory operations with broader clinical, operational, and business objectives
• Provide high-level customer service and issue resolution to internal and external stakeholders
• Ensure clear communication of performance expectations, priorities, and status updates

Requirements

Comprehensive knowledge of GCP, FDA regulations, IRB requirements, and sponsor expectations

In-depth understanding of clinical trial lifecycle and regulatory processes (startup, maintenance, closeout)

Knowledge of regulatory compliance frameworks, CAPA processes, and audit/inspection readiness standards

Familiarity with organizational SOPs, systems, and operational workflows supporting regulatory activities

Understanding of performance metrics, KPIs, and risk indicators used to manage regulatory operations

Knowledge of process improvement methodologies, transformation initiatives, and system optimization strategies

At least five years of research experience within research sites or industry

At least five years of management experience with direct reports

At least five years of experience working within a research startup team

Research certification (ACRP or CCRP) preferred

Bachelor Degree required

Skills

Strong leadership, strategic thinking, and operational discipline

Excellent communication, influence, and customer service skills

Benefits

Comprehensive benefits to support physical, mental, and financial well-being

Competitive compensation package including base pay, annual bonus, and long-term incentive opportunities

Pay

Commensurate with experience

Schedule

N/A