Sr. Regulatory Affairs Specialist, Controlled Substances Monitoring Program (CSMP)

McKesson • Irving, TX

29d • Hybrid

About The Position

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. Position Summary 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level