Sr. Associate Regulatory Affairs Specialist

McKesson•Mason, KY

About The Position

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.

Requirements

Degree or equivalent and typically requires 2+ years of relevant experience.
Previous experience in Regulatory Affairs, pharmaceutical distribution/manufacturing, quality, healthcare, supply chain compliance, or another regulated environment.
Working knowledge of DSCSA product tracing, product identifiers, serialized transaction data, EPCIS, verification, quarantine, Suspect Product, and recordkeeping concepts.
Demonstrated experience reviewing regulatory/compliance cases or conducting investigations.
Strong regulatory judgment, analytical thinking, documentation, and problem-solving skills.
Ability to independently manage multiple priorities and lead cross-functional meetings and initiatives.
Strong written and verbal communication skills.

Responsibilities

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 regulatory discussions regarding investigation and reporting requirements.
Coordinate assessment of applicable events for potential DEA Form 106 reporting with CSMP, Legal, and appropriate subject-matter experts.
Evaluate theft, shortage, and loss events for potential Suspect Product indicators and escalate significant or recurring trends.
Lead routine cross-functional reviews of newly reported Suspect Product, theft, shortage, loss, DSCSA exceptions, and significant product-integrity events.
Establish appropriate ownership, investigation pathway, regulatory assessment, escalation, next actions, and documented handoffs between operational, technical, Quality, and Regulatory Affairs owners.
Track critical investigations and facilitate timely completion of outstanding actions and escalation of potentially reportable or significant regulatory matters.
Partner with Transportation to ensure applicable shortage, theft, loss, and unexplained product-discrepancy complaints are appropriately captured in IMS.
Ensure events received directly by operational departments receive Regulatory Affairs visibility when regulatory assessment may be required.
Evaluate related events collectively to identify patterns that may indicate Suspect Product or broader product-integrity concerns.
Coordinate with Operations, Inventory Services, Quality, Transportation, and other stakeholders to obtain information necessary to support investigations.
Maintain and analyze metrics for Salesforce RA cases, Suspect Product investigations, theft/loss events, DSCSA/serialization investigations, regulatory escalations, and IMS investigation aging.
Monitor turnaround times, aging investigations, and high-risk matters and provide management reporting on significant events and emerging compliance risks.
Analyze DSCSA exceptions by exception type, process step, facility, client, supplier/trading partner, system, and root cause, when data is available.
Conduct trend analysis to identify recurring regulatory, operational, and product-integrity risks and opportunities to reduce repeat events and operational disruption.
Support development and revision of Regulatory Affairs policies, SOPs, work instructions, job aids, and training.
Participate in audits, inspections, CAPAs, system enhancements, and continuous-improvement initiatives.
Support additional Regulatory Affairs and DSCSA responsibilities based on departmental priorities.