Director of Regulatory Affairs

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

PURPOSE OF THE ROLE

The Director of Regulatory Affairs provides strategic leadership and oversight of regulatory and quality compliance across McKesson’s Private Label portfolio. This role integrates the Regulatory Affairs and Quality Compliance functions under a single point of accountability to enable sustained market access, product integrity, and inspection readiness.

Operating at the intersection of regulatory execution, quality systems oversight, and business enablement, this role ensures that regulatory strategy and quality compliance programs are seamlessly aligned with evolving U.S. and international requirements, internal policies, and enterprise objectives.

As a senior people leader, the Director is responsible for shaping the long-term vision, developing future talent, and embedding a culture of accountability, agility, and operational excellence. The Director serves as the primary enterprise voice of Regulatory Affairs and Quality Compliance -internally, within governance forums and executive decision-making, and externally, in regulatory inspections, industry associations, and policy dialogues. This role is also a sponsor for digital transformation, driving the adoption of technology solutions, automation, and analytics to modernize compliance oversight and improve enterprise performance.

 

KEY RESPONSIBILITIES

• Strategic Leadership & Organizational Excellence
  • Define and execute the integrated Regulatory Affairs and Quality Compliance strategy, aligning with FDA, ICH, DEA, CBP, and international frameworks to ensure compliant growth and sustained market access.
  • Advise executive leadership on regulatory and quality compliance posture, operational risk, and business impact, shaping internal policy and influencing enterprise direction.
  • Lead, develop, and inspire a high-performing integrated Regulatory Affairs and Quality Compliance leadership team, fostering a culture of transparency, accountability, and regulatory and quality excellence.
  • Oversee organizational design, succession planning, and capability development to build resilient, future-ready talent pipelines.
  • Manage headcount planning, resource allocation, and budget alignment to support enterprise priorities.
  • Deliver enterprise visibility through advanced dashboards, risk-based reporting, and data-driven insights to inform senior decision-making
  • Represent Regulatory Affairs and Quality Compliance in enterprise governance forums, ensuring regulatory and quality perspectives are embedded in strategic planning and risk management.
     
• Regulatory Affairs and Quality Compliance Strategy
  • Provide end-to-end strategic oversight of all regulatory submissions and product labelling initiatives for both new and mature products, ensuring alignment with global registration requirements and ongoing compliance standards.
  • Lead post-market programs, including adverse event monitoring, medical information, complaints handling, and Risk Evaluation and Mitigation Strategies (REMS). Ensure readiness for recalls and timely regulatory reporting.
  • Oversee the development, implementation, and continuous improvement of the Quality Management System to support compliance with applicable regulatory and quality standards across all product categories.
  • Oversee compliance with Controlled Substance Monitoring Programs (CSMP) and DSCSA suspect/illegitimate product investigations.
  • Act as a principal regulatory representative during inspections, audits, and regulatory engagements, ensuring organizational readiness and providing authoritative guidance.
  • Represent the company with regulatory agencies and industry bodies, safeguarding organizational credibility and influencing evolving policy landscapes.
  • Ensure robust compliance policies and procedures reflect emerging regulatory requirements, global distribution models, and evolving business needs.
  • Partner cross-functionally with Quality, Supply Chain, Legal, Commercial, and Compliance functions to integrate Regulatory Affairs & Quality Compliance considerations into business processes
  • Drive enterprise-wide signal detection and root cause analytics to proactively identify and mitigate product risks.
  • Ensure agreements, auditing programs, and monitoring mechanisms are in place for all third-party partners and service providers.
  • Lead enterprise responses to regulatory escalations, market actions, or compliance crises, ensuring timely, coordinated, and compliant resolution
  • Define and track regulatory performance metrics (KPIs), driving continuous improvement, right-first-time execution, and alignment with enterprise compliance and operational goals
     
• Digital Transformation & Innovation
  • Serve as the executive sponsor for regulatory and quality digital transformation initiatives, driving the adoption of technology solutions, automation, and analytics.
  • Advance integration and optimization of regulatory and quality platforms to modernize workflows, reduce manual effort, and increase visibility.
  • Promote innovation in compliance execution, enabling right-first-time outcomes and sustainable scalability.

REQUIREMENTS

Education:

• Bachelor’s degree or higher in Chemistry, Microbiology, Pharmaceutical Sciences, or a related field.
   

Experience:

• Minimum 12+ years of progressive experience in Regulatory Affairs, Quality Compliance, or related functions within the pharmaceutical, biologics, or medical device industry.
• Minimum 4+ years in a people leadership role, including responsibility for building teams, driving strategy, and influencing enterprise decisions.
• Proven track record managing regulatory submissions, labelling, post-market activities, and quality systems oversight.
• Demonstrated success engaging with global health authorities, leading inspections/audits, and influencing enterprise-level decisions.
• Experience in private label, distributed product business models, and oversight of third-party manufacturers/service providers is strongly preferred.

Key Skills & Competencies:

• Integrated Regulatory & Quality Leadership: Deep knowledge of U.S. and global regulatory frameworks (FDA, ICH, DEA, CBP) and GxP-aligned quality systems.
• Enterprise Leadership: Skilled in leading large, diverse teams, shaping organizational structures, and developing next-generation leaders.
• Risk & Compliance Strategy: Expertise in inspection readiness, risk management, issue resolution, and regulatory intelligence.
• Executive Influence: Skilled communicator with the ability to simplify complexity, engage senior stakeholders, and represent the enterprise to regulators.
• Digital Fluency: Proficiency with regulatory and quality platforms and digital tools to drive transformation.
• Change Leadership: Ability to lead through ambiguity, balancing compliance rigor with agility and business continuity.
• Business Acumen: Strong ability to align compliance objectives with commercial priorities to enable sustainable growth.
• Risk & Response Management: Calm, strategic, and decisive under pressure; experienced in managing regulatory crises, recalls, or escalations in collaboration with Legal, Quality, and executive stakeholders.
   

Technical Proficiency:

• Advanced Proficiency in Regulatory and Quality Management applications, supporting document control, workflow automation, and compliance assurance.
• Highly proficient in using SharePoint, and integrated platforms to facilitate global team coordination and secure document collaboration.
• Proficient in Smartsheet, with capability in building dynamic project dashboards, managing cross-functional timelines, and driving visibility across regulatory initiatives
• Adept at leveraging digital platforms to streamline regulatory workflows, improve visibility, and support compliance with industry best practices.
   

Work Environment:

• Hybrid work model; ability to work from home and in the general office environment.
• Occasional international travel required for business needs

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.  In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Our Base Pay Range for this position