McKesson · 8 hours ago
Sr. Regulatory Affairs Specialist, Controlled Substances Monitoring Program (CSMP)
Irving, TX
Full-time
Hybrid
Mid, Senior Level
$106K/yr - $176K/yr
7+ years expMcKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. The Sr. Regulatory Affairs Specialist plays a critical role in ensuring compliance with Controlled Substances Monitoring Program (CSMP) policies and procedures while collaborating across departments to uphold regulatory excellence.
BiopharmaBiotechnologyHealth CareInformation TechnologyPharmaceutical
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
Qualification
Required
Degree or equivalent and typically requires 7+ years of relevant experience
Minimum 7 years of progressive experience in compliance, regulatory, or legal roles within healthcare or pharmaceutical environments
Demonstrated knowledge of federal and state regulations governing controlled substances distribution and dispensing
Exceptional written and verbal communication skills, including experience preparing executive-level reports and presentations
Proven ability to manage complex projects from inception to implementation, delivering on time and within scope
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and familiarity with generative AI tools
Ability to accurately manage and review complex regulatory documentation and compliance processes, ensuring precision and adherence to requirements
Undergraduate degree or equivalent professional experience
Preferred
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
Benefits
Competitive compensation package
Annual bonus
Long-term incentive opportunities
Company
McKesson
McKesson distributes medical supplies, information technology, and care management products and services.
10001+ employees
H1B Sponsorship
McKesson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (149)
2024 (129)
2023 (82)
2022 (142)
2021 (144)
2020 (154)
Funding
Current Stage
Public CompanyTotal Funding
unknown1994-11-18IPO
Leadership Team
Brian Tyler
CEO
Jim McAuliffe
CFO
Recent News
2026-02-06
2026-02-06
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2026-02-05
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