Sr. Associate Regulatory Affairs Specialist

McKesson Corporation • Mason, OH • 1h ago

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 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.

KEY RESPONSIBILITIES

Suspect Product & DSCSA Management

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.

3PL DSCSA Exceptions & Operational Bridge

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

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