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

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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.

Key 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.

Minimum Requirement

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

Must-Have 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-Have 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.

Physical Requirements

• 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 inoffice 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 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

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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 welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you require accommodation please contact us by sending an email to Disability_Accommodation@McKesson.com.

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