Sr. Regulatory Affairs Specialist, Controlled Substances Monitoring Program; CSMP

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The Sr. Regulatory Affairs Specialist plays a critical role in ensuring McKesson’s compliance with Controlled Substances Monitoring Program (CSMP) policies and procedures, as well as obligations under a nationwide opioid litigation settlement agreement. This position focuses on optimizing compliance processes for efficiency and scalability, while supporting governance activities and engagement with a third-party monitor. Reporting to the Sr. Director of Regulatory Affairs, this role collaborates across departments to uphold McKesson’s commitment to regulatory excellence and controlled substance compliance.

• Design and support processes to monitor ongoing compliance with CSMP policies and procedures.

• Develop and implement processes to ensure adherence to injunctive relief provisions under the nationwide opioid litigation settlement.

• Support engagement with a third-party monitor during annual reviews required by the injunctive relief provisions of the nationwide opioid litigation settlement.

• Support CSMP governance activities, including preparing reports and materials for governance-related meetings.

• Coordinate cross-functional efforts with internal departments to meet CSMP requirements.

• Provide strategic guidance to senior leadership on compliance and governance matters.

Degree or equivalent and typically requires 7+ years of relevant experience.

• Experience: Minimum 7 years of progressive experience in compliance, regulatory, or legal roles within healthcare or pharmaceutical environments.

• Regulatory Expertise: Demonstrated knowledge of federal and state regulations governing controlled substances distribution and dispensing.

• Communication: Exceptional written and verbal communication skills, including experience preparing executive-level reports and presentations.

• Project Management: Proven ability to manage complex projects from inception to implementation, delivering on time and within scope.

• Technical
  
  Skills:
  
  Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and familiarity with generative AI tools.

• Attention to Detail: Ability to accurately manage and review complex regulatory documentation and compliance processes, ensuring precision and adherence to requirements.

• Education: Undergraduate degree or equivalent professional experience.

• Prior experience interacting with federal or state regulators in the pharmaceutical supply chain.

• Background in controlled substance compliance and diversion programs.

• Ability to thrive in a collaborative, matrixed organization as an effective team player.

• Results-oriented mindset with strong attention to detail.

• Location – Irving, TX;
  Alpharetta, GA; or Washington, DC. Remote work may be considered for the right candidate.

• General Office demands.

* Candidates based in the Dallas–Fort Worth (DFW) area will be hired in a hybrid capacity and are expected to work onsite at our Las Colinas office a minimum of two (2) days per week, with the remaining days worked remotely. Specific in-office days may be designated based on team needs and business priorities.

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…