Regulatory Affairs Specialist

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.

Summary   The Regulatory Affairs Manager (P3), Complex Molecules & Specialized Distribution Programs, supports regulatory compliance for pharmaceutical products requiring enhanced, product-specific, or overlapping distribution controls within pharmaceutical logistics and third-party logistics operations. This role serves as an advanced professional contributor and operational regulatory subject matter expert for products that may be governed by multiple FDA, DEA, state board of pharmacy, manufacturer, quality, security, licensing, patient-safety, and distribution requirements.   The position supports specialty pharmaceuticals, biologics, Risk Evaluation and Mitigation Strategy (REMS) products, controlled substances, limited-distribution products, cell and gene therapies, and other complex therapies requiring specialized handling or compliance controls. The role translates regulatory and manufacturer requirements into practical operational processes, evaluates compliance risk, supports product onboarding and change implementation, investigates exceptions, and maintains inspection and audit readiness.   The position partners with Quality Assurance, Operations, Security, Customer Service, Licensing, Legal, Commercial, Technology, Supply Chain, and pharmaceutical manufacturers to support compliant execution across the product lifecycle.

Complex Product & Program Oversight   Serve as a regulatory resource for complex molecules and specialized distribution programs requiring enhanced or overlapping compliance controls.   Assess product-specific obligations involving FDA, DEA, state pharmacy, manufacturer, quality, licensing, security, patient-safety, and distribution requirements.   Translate complex regulatory and manufacturer requirements into scalable operational controls, procedures, decision criteria, and monitoring activities.   Identify conflicts, gaps, dependencies, and unintended consequences where multiple regulatory or contractual requirements apply.   Evaluate proposed process, system, facility, customer, or product changes for regulatory impact and recommend practical risk controls.   Provide risk-based escalation and recommendations to leadership when requirements are unclear, conflicting, or operationally difficult to execute.   REMS & Restricted Distribution Compliance   Support implementation and ongoing maintenance of manufacturer REMS and restricted-distribution program requirements within distribution and fulfillment operations.   Interpret Elements to Assure Safe Use (ETASU), certification, enrollment, customer eligibility, distribution limitation, documentation, reporting, and attestation requirements.   Monitor REMS-related exceptions, program metrics, customer eligibility outcomes, and recurring compliance trends.   Support manufacturer audits, governance meetings, program reviews, corrective actions, and remediation activities.   Assist with development and revision of policies, SOPs, work instructions, job aids, and training materials supporting assigned programs.   Controlled Substance & Dual-Regulated Product Support   Support regulatory compliance activities for controlled substances handled by distribution or 3PL operations, particularly where additional REMS, restricted-distribution, or manufacturer controls apply.   Assist with review and