Senior Associate, Regulatory Affairs Specialist

• Lead day-to-day Suspect Product investigations from notification through investigation, disposition, and closure
• Facilitate cross-functional investigation and review meetings, establishing ownership, actions, escalation pathways, and timelines
• Evaluate incidents for Suspect Product and Illegitimate Product indicators and determine investigation or escalation
• Support DSCSA verification, quarantine, product tracing, disposition, and documentation requirements
• Support serialization investigations involving GTIN/NDC, serial numbers, lot/expiration, SSCC, EPCIS, and transaction information
• Serve as the Regulatory Affairs bridge for DSCSA exceptions across receiving, inventory movement, fulfillment, shipping, delivery, returns, and disposition
• Coordinate containment and align physical product, system inventory, and serialized-data status
• Coordinate theft, shortage, unexplained loss, controlled-substance, and potential DEA Form 106 reporting assessments
• Lead cross-functional reviews and track critical investigations through completion
• Maintain and analyze regulatory case, investigation, theft/loss, DSCSA, escalation, and aging metrics
• Provide management reporting on significant events and emerging compliance risks
• Support policies, SOPs, training, audits, inspections, CAPAs, system enhancements, and continuous-improvement initiatives

• Degree or equivalent and typically 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

Demonstrates expertise in Regulatory Affairs and compliance within pharmaceutical distribution, focusing on DSCSA verification, product tracing, and investigation management. Capable of leading cross-functional initiatives and maintaining regulatory documentation and metrics.

• Regulatory Affairs Experience
• DSCSA Product Tracing
• Investigation Management
• Analytical Thinking
• Strong Communication Skills

• Product Tracing
• Serialized Transaction Data
• EPCIS
• Documentation Requirements
• Regulatory Compliance
• Incident Evaluation
• Quarantine Procedures
• Theft Reporting Assessments
• Metrics Analysis
• Continuous Improvement Initiatives

• Analytical Thinking
• Problem-Solving Skills
• Ability to Manage Multiple Priorities
• Leadership in Cross-Functional Meetings
• Strong Written Communication

• Pharmaceutical Distribution
• Quality Assurance
• Healthcare Compliance
• Supply Chain Compliance
• Regulated Environment
• SOPs
• CAPAs
• Inspections
• Inventory Movement
• Controlled-Substance Reporting