Sr. Associate 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.

The Senior Associate Regulatory Affairs Specialist provides day-to-day regulatory leadership and oversight supporting 3PL operations, with primary responsibility for Suspect Product program leadership, DSCSA/serialization exceptions, theft and loss coordination, and regulatory investigation management.

This role serves as a centralized Regulatory Affairs resource connecting operational events, physical product status, serialized data, and regulatory requirements. The position partners cross-functionally with Regulatory Affairs, CSMP, Transportation, Quality Assurance, Operations, Inventory Services, DSCSA/Serialization, Master Data, Information Technology, Account Management, Legal, manufacturers, clients, trading partners, and other stakeholders to ensure regulatory matters are timely identified, contained, documented, investigated, escalated, resolved, and closed.

The position evaluates potential compliance risks, product-integrity concerns, theft/loss events, and Suspect or Illegitimate Product indicators and ensures appropriate ownership, regulatory assessment, and documented disposition.

• Lead day-to-day Suspect Product investigations from initial notification through investigation, disposition, and closure.
• Facilitate cross-functional investigation/review meetings and establish ownership, actions, escalation pathways, and timelines.
• Evaluate incidents for Suspect Product and Illegitimate Product indicators and determine appropriate investigation or escalation.
• Support DSCSA requirements related to verification, quarantine, product tracing, disposition, and documentation.
• Support serialization investigations involving product identifiers, GTIN/NDC, serial numbers, lot/expiration, aggregation/SSCC, EPCIS, transaction information, and related discrepancies.
• Partner with DSCSA subject-matter experts on complex product-tracing and serialization matters.
• Monitor investigation aging and ensure regulatory decisions, supporting evidence, and closure documentation are maintained in IMS.

• Serve as the Regulatory Affairs bridge for DSCSA exceptions across receiving, inventory movement, fulfillment, shipping, delivery, returns, and product disposition.
• Differentiate routine operational, system, master-data, or trading-partner data issues from events potentially involving Suspect Product, diversion, theft, loss, or other product-integrity concerns.
• Coordinate initial containment and ensure physical product, system inventory, and serialized-data status remain aligned during investigations.
• Connect Operations, Quality, Inventory Services, Transportation, Master Data, DSCSA/Serialization, IT, Account Management, manufacturers, clients, and trading partners to establish clear ownership, evidence requirements, next actions, and escalation timing.
• Ensure investigation records appropriately capture applicable product, location, GTIN/NDC, serial number, lot, expiration, SSCC/aggregation, shipment/order, EPCIS, screenshots, communications, and findings.
• Coordinate product-identifier verification and transaction-data research with manufacturers, clients, solution providers, and trading partners and track responses through resolution.
• Identify recurring exception types, failure points, ownership gaps, root causes, and aging trends and recommend corrective actions, system enhancements, SOP updates, training, or escalation.
• Maintain complete case histories, decision rationale, role clarity, and supporting evidence to support DSCSA audit and inspection readiness.

• Serve as a Regulatory Affairs Theft and Loss Coordinator helping triage initial events and ensuring issues are being logged accordingly.
• Partner with CSMP to review reported theft, shortage, unexplained loss, and controlled-substance events.
• Lead or facilitate…