Director of Central Regulatory

About the role

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

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

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

Qualifications

• 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

We not only care about the wellbeing of our patients, customers and the communities we serve — we care about you. That’s why we provide our employees with a comprehensive support system for all aspects of Your Care: physical, emotional, financial and social.

Pay

Competitive compensation package based on performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Schedule

Flexible schedule to accommodate the needs of the role and the patient population.