Director of Central Regulatory

McKesson•Nashville, TN

About The Position

As the Director of Central Regulatory, you are responsible for the end-to-end leadership, oversight, and performance of regulatory operations, ensuring the delivery of high-quality, compliant, and timely regulatory outcomes across the portfolio. This role provides both strategic direction and hands-on operational leadership, driving execution through clear governance, risk management, and accountability frameworks. You will partner closely with cross-functional Site Support Operations teams and the broader Site Management Organization, as well as site research teams and investigators, to evaluate, align, and optimize ongoing regulatory processes. You will ensure cross-functional coordination to enable efficient, scalable, and inspection-ready execution that meets or exceeds organizational, regulatory, and sponsor expectations. This role requires excellent communication, influence, and customer service skills to effectively engage and partner with internal stakeholders and external partners, including sponsors, CROs, IRBs, investigators, and physicians.

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
Bachelor Degree required

Nice To Haves

Research certification (ACRP or CCRP) preferred

Responsibilities

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
Ensure timely, accurate, and inspection-ready regulatory submissions, approvals, and maintenance activities across the full study lifecycle
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
Serve as a key escalation point to resolve complex operational and regulatory issues across sites and studies
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
Lead or support process improvement and transformation initiatives, including automation and system enhancements
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