Senior Director, Regulatory Affairs Program Modernization

MCK McKesson Corporation; Irving (TX); Hybrid; USD 189,000 - 315,000; Full time

Benefits offered by this job

Hybrid work environment

Competitive compensation package

Job summary

McKesson is seeking a Senior Director, Regulatory Affairs Program Modernization to lead a multi-year modernization of the Controlled Substances Monitoring Program (CSMP). This role reports to the VP of Regulatory Affairs and will drive AI-enabled capabilities, governance, data quality, and automation across regulatory, legal, compliance, technology, and vendor partnerships.

You will define a future-state operating model, establish governance, and ensure audit readiness while maintaining

Qualifications

• 13+ years of experience leading transformation, program management, regulatory, compliance, or technology initiatives within healthcare or other highly regulated industries.
• 8+ years of experience leading large-scale, cross-functional modernization, transformation, or digital modernization programs.
• Experience translating regulatory, operational, 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.

Responsibilities

• Develop and execute the strategic roadmap for modernization of the CSMP.
• Partner with Regulatory Affairs leadership to advance AI, automation, analytics, governance and process-improvement initiatives.
• Evaluate current-state processes, systems, controls, and data flows to identify opportunities for efficiency, scalability, quality, and compliance.
• Lead the design of future-state operating models and technology-enabled solutions aligning regulatory, operational and business needs.
• Drive cross-functional programs with Regulatory Affairs, Legal, Compliance, Technology, and external vendors.
• Establish program governance, metrics, roadmaps, milestones, and risk management practices.

Skills

Regulatory affairs

Program management

Transformation leadership

AI/Automation

Data analytics

Stakeholder management

Education

Bachelor's degree in Business/Technology/Engineering/Healthcare Administration

Advanced degree preferred

Job description

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.

About the Role 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. This leader will partner 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.

What You'll Do

• 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 that align 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.

Basic Requirements

• Degree or equivalent and typically requires 13+ years, with 8+ years, of direct work-related experience. Less years required if candidate has relevant Master's or Doctorate qualifications.
• 13+ 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.

Preferred Skills/Experience

• Bachelor's degree in Business, Technology, Engineering, Data Analytics, Healthcare Administration, or a related field.
• Advanced degree preferred.
• 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.

Travel, Work Environment & Physical Requirements

• Hybrid work environment.
• Preferred location: Las Colinas, TX.
• Candidates located in the Dallas-Fort Worth area are expected to work on-site at the Las Colinas office a minimum of two (2) days per week, with the remaining days worked remotely.
• Limited travel may be required based on business needs.
• Ability to work at a computer and communicate effectively with internal and external stakeholders.

McKesson complies with all applicable U.S. immigration laws and regulations.

The Company does not provide employer support or sponsorship for any immigration related employment benefit for this role. Applicants must be currently authorized to work in the United States on a fulltime basis without the need for employer support or sponsorship now or in the future. This includes having the legal right to work in the United States without the need for McKesson support or sponsorship for any immigration related employment authorization (e.g., H1B, O1, E3, H1B1, TN, F1 OPT, F1 STEM OPT, F1 CPT, etc.) now or in the future. If you will require McKesson to provide immigration support or sponsorship now or in the future, you should not apply for this position.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. 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. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position $189,000 - $315,000

McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) [e-mail] or (Canada) [e-mail]. Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!

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.