McKesson

Director of Central Regulatory

McKesson • $130K — $180K *
US-AnywhereRemote in Nashville, TN
Pharmaceuticals & Biotech
5 - 7 years of experience
3 weeks ago
Job Overview by Ladders

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

Responsibilities

  • Establish and maintain regulatory compliance and quality standards
  • Oversee CAPA, non-compliance investigations, and issue resolution
  • Proactively identify, assess, and mitigate regulatory and operational risks
  • Ensure adherence to GCP, IRB requirements, and internal SOPs
  • Provide oversight and direction for study startup and ongoing regulatory maintenance activities
  • Serve as a key escalation point to resolve complex operational and regulatory issues
  • Lead, develop, and optimize the regulatory organization by driving performance accountability

Benefits

  • Opportunities for professional development and career progression
  • Engagement in high-impact regulatory strategy and execution
  • Dynamic and collaborative work culture
  • Access to process improvement and transformation initiatives
  • Participation in a performance-driven organization focused on quality and efficiency
Full Job Description
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.

You must demonstrate strong leadership, strategic thinking, and operational discipline, with the ability to balance high-level direction and detail-oriented execution in a complex, fast-paced environment. 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.
  • 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


You should have for this position:
  • 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

About McKesson

McKesson Corporation provides medicines, pharmaceutical supplies, information and care management products and services across the healthcare industry. The Company operates in two segments. The McKesson Distribution Solutions segment delivers ethical drugs, medical-surgical supplies and equipment and health and beauty care products throughout North America. This segment also provides specialty pharmaceutical solutions for biotech and pharmaceutical manufacturers, sells financial, operational and clinical solutions for pharmacies (retail, hospital, long-term care) and provides consulting, outsourcing and other services. The McKesson Technology Solutions segment delivers enterprise-wide clinical, patient care, financial, supply chain, strategic management and software solutions. In July 2011, the Company acquired Portico Systems from Safeguard Scientifics, Inc. On March 25, 2012, it acquired the independent banner and franchise businesses of Katz Group Canada Inc. McKesson Distribution Solutions delivers pharmaceuticals to retail pharmacies and institutional providers like hospitals and health systems. They operate pharmaceutical distribution centers across the country, serving customers in all 50 states. They also deliver a comprehensive offering of health care products, technology, equipment and related services to the alternate site market, including physician offices, surgery centers, long-term care facilities and home care businesses across the country. McKesson is currently the largest pharmaceutical distributor in North America. McKesson also operates McKesson Canada and has an equity holding in Nadro, a leading distributor in Mexico.

McKesson Careers

Join McKesson, a leading global healthcare company, and be part of a team that is redefining the future of healthcare. With a variety of job opportunities available, McKesson is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At McKesson, we are committed to improving care in every setting—one product, one partner, one patient at a time. We’re seeking talented professionals to join our team and contribute to a culture of innovation, diversity, and leadership. Our employees are driven by a deep sense of purpose and a desire for continuous growth and improvement. Empower Your Future in Healthcare With positions ranging from internships to leadership roles, McKesson offers unparalleled employment opportunities to develop your skills and advance your career. Our commitment to diversity training ensures that all team members have the opportunity to thrive. Join a team where your skills will be honed, your professional growth will be supported, and where you can genuinely see the difference you make in the lives of patients around the world. Innovative Work Environment McKesson is at the forefront of healthcare innovation. Our team is constantly exploring new ways to improve patient outcomes and streamline care processes. This commitment to innovation is what sets us apart and what makes McKesson an exciting place to work. Career Development and Benefits McKesson believes in nurturing the potential of its employees through robust career development programs and comprehensive benefits designed to support your life and well-being. From leadership training to health and wellness benefits, we ensure our team members are equipped to meet their professional and personal goals. Explore Job Opportunities Whether you’re looking for an internship to kickstart your career, or a senior position to utilize your extensive experience, McKesson offers a range of opportunities. Explore our open positions and find where you can make a difference at McKesson. Stay Connected Join Our Team Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take the next step in their careers. Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Networking and Professional Growth At McKesson, networking and professional growth are part of our everyday environment. We encourage our employees to connect, share, and learn from each other to foster personal and professional development. Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await you at McKesson. Join McKesson today and be part of a team that is dedicated to shaping the future of healthcare.
Learn more about McKesson
Size
58,000 employees
Market Cap
$53.7 billion
Industry
Pharmaceuticals & Biotech
Net Income
-$4.1 billion
Founded
1833
5 Year Trend
+5.9%
Revenue
$237.6 billion
NASDAQ
MCK
* Ladders Estimates

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