Senior Director, Regulatory Affairs Program Modernization
Irving, TX - USA
Job Summary
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 tomorrows 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.
The ideal candidate combines expertise in healthcare regulatory environments with a proven track record leading enterprise transformation digital modernization and complex cross-functional programs.
What Youll 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 Masters 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
- Bachelors 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 McKessons 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 pleaseclick here.
Our Base Pay Range for this position
$189000 - $315000McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKessons (or affiliated entities like CoverMyMeds or RxCrossroads) name in fraudulent emails job postings or social media light of these scams please bear the following in mind:
McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.
McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.
McKesson job postings are posted on our career site: .
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 McKessons 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) or (Canada) . Resumes or CVs submitted to this email box will not be accepted.
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About Company
McKesson is the leading healthcare company for wholesale medical supplies & equipment, pharmaceutical distribution, and healthcare technology solutions. McKesson is the central nervous system of health care. At any given moment, in any given minute, we simultaneously execute thousands ... View more