Senior Associate, Regulatory Affairs Specialist

Jobtailor; Kentucky; On-site; USD 70,000 - 100,000; Full time

Job summary

Jobtailor seeks an experienced Regulatory Affairs Investigator in Kentucky to lead suspect product investigations from notification through closure. You will coordinate cross-functional meetings, assess DSCSA-related indicators, and ensure compliant documentation and reporting across the distribution chain.

Ideal candidates bring 2+ years in regulatory/compliance roles, strong analytical skills, and the ability to manage multiple priorities while guiding teams to timely resolutions.

Qualifications

• Bachelor's degree or equivalent with 2+ years of relevant experience.
• Experience in Regulatory Affairs, pharmaceutical distribution, quality, or a regulated environment.
• Working knowledge of DSCSA product tracing, EPCIS, serialization data, verification and recordkeeping concepts.
• Experience reviewing regulatory/compliance cases or investigations.
• Strong regulatory judgment, analytical thinking, documentation, and problem-solving skills.
• Ability to independently manage multiple priorities and lead cross-functional meetings.

Responsibilities

• Lead day-to-day suspect product investigations from notification to disposition and closure.
• Facilitate cross-functional investigation meetings, establish ownership, actions, escalation pathways, and timelines.
• Evaluate incidents for suspect product and illegitimate product indicators and determine escalation.
• Support DSCSA verification, quarantine, product tracing, and documentation requirements.
• Coordinate containment and align physical product, system inventory, and serialized-data status.
• Lead cross-functional reviews and track 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.

Skills

Regulatory Affairs

DSCSA Product Tracing

Investigation Management

Analytical Thinking

Strong Communication Skills

Education

Bachelor's degree or equivalent

Tools

EPCIS

Job description

• 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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

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

Soft Skills

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

Industry Keywords

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