Senior Director, Regulatory Affairs Program Modernization
About The Position
McKesson is seeking a Senior Director, Regulatory Affairs Program Modernization to lead the strategic evolution of its Controlled Substances Monitoring Program (CSMP). Reporting to the Vice President, Regulatory Affairs, this role will define and execute a multi-year modernization strategy focused on process transformation, AI-enabled capabilities, data governance, automation, and operational excellence. The role partners across Regulatory Affairs, Legal, Compliance, Technology, and external partners to implement scalable, technology-enabled solutions that improve efficiency, strengthen governance, and maintain regulatory compliance and audit readiness. The ideal candidate brings healthcare regulatory expertise and a track record leading enterprise transformation, digital modernization, and complex cross-functional programs.
Requirements
- Degree or equivalent; typically requires 13 or more years of experience, including 8 or more years of direct work-related experience. Fewer years may be required with relevant Master's or Doctorate qualifications.
- 13 or more years of experience leading business transformation, program management, operations, regulatory, compliance, or technology initiatives within healthcare or other highly regulated industries.
- Experience leading large-scale, cross-functional modernization, transformation, process improvement, or digital transformation programs.
- Experience translating regulatory, operational, business, data, and control requirements into scalable processes and technology-enabled solutions.
- Experience working with artificial intelligence, automation, data analytics, or digital modernization initiatives.
- Ability to manage confidential, proprietary, and sensitive information.
- Applicants must be currently authorized to work in the United States on a full-time basis without the need for employer support or sponsorship now or in the future.
Nice To Haves
- Bachelor's degree in Business, Technology, Engineering, Data Analytics, Healthcare Administration, or a related field.
- Advanced degree.
- Experience with regulatory affairs, compliance programs, governance frameworks, risk management, or internal controls.
- Knowledge of Responsible AI principles, model governance, explainability, validation, monitoring, and human oversight controls.
- Experience partnering with enterprise technology teams, software vendors, consulting firms, and third-party service providers.
- Strong executive communication, stakeholder management, and influencing skills.
- Demonstrated success leading organizational change, adoption, communication, and training initiatives.
- Experience developing operating models, governance structures, and enterprise transformation roadmaps.
Responsibilities
- Develop and execute the strategic roadmap for modernization of the Controlled Substances Monitoring Program (CSMP).
- Partner with Regulatory Affairs leadership to advance business transformation initiatives involving AI, automation, analytics, governance, and process improvement.
- Evaluate current-state processes, systems, controls, and data flows to identify opportunities to improve operational efficiency, scalability, quality, and compliance.
- Lead the design of future-state operating models and technology-enabled solutions aligned with regulatory, operational, and business requirements.
- Drive cross-functional programs involving Regulatory Affairs, Legal, Compliance, Technology, and external vendors.
- Establish program governance, success metrics, roadmaps, milestones, and risk management practices to ensure successful delivery of strategic outcomes.
- Ensure AI-enabled solutions align with responsible AI principles, data governance standards, privacy requirements, auditability expectations, and internal policies.
- Design and implement change management strategies that support adoption of new processes, technologies, and ways of working.
- Maintain regulatory compliance, defensible documentation, decision-making controls, and audit readiness throughout transformation efforts.
- Provide executive-level recommendations and influence leaders across the organization on modernization priorities and investments.
Benefits
- Competitive compensation package as part of McKesson's Total Rewards.
- Annual bonus or long-term incentive opportunities may be offered.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
