Regulatory Affairs Specialist Job Jeffersontown area,Kentucky USA,Quality Assurance

Serve as a regulatory resource for complex molecules and specialized distribution programs
Assess product‑specific FDA, DEA, state pharmacy, manufacturer, quality, licensing, security, patient‑safety, and distribution obligations
Translate regulatory and manufacturer requirements into operational controls, procedures, decision criteria, and monitoring activities
Identify conflicts, gaps, dependencies, and unintended consequences across overlapping requirements
Evaluate process, system, facility, customer, and product changes for regulatory impact
Support implementation and maintenance of manufacturer REMS and restricted-distribution programs
Monitor REMS exceptions, metrics, customer eligibility outcomes, and compliance trends
Support manufacturer audits, governance meetings, program reviews, corrective actions, and remediation
Develop and revise policies, SOPs, work instructions, job aids, and training materials
Support controlled‑substance compliance, investigations, documentation, and notification activities
Lead or support regulatory assessments for new specialty products, biologics, cell and gene therapies, and complex therapies
Participate in launch‑readiness reviews and confirm controls, documentation, training systems, and escalation paths
Monitor regulatory and manufacturer program developments and perform impact assessments
Investigate compliance concerns, complaints, deviations, and process failures
Lead or support root cause analysis and corrective and preventive actions
Maintain documentation for regulatory interpretations, risk decisions, investigations, and compliance assessments
Support FDA, DEA, state board, manufacturer, client, and internal audits or inspections
Provide regulatory guidance and training to internal stakeholders
Facilitate cross‑functional issue resolution and communicate with manufacturers and external program administrators
Participate in business‑development and client‑onboarding activities requiring specialized regulatory expertise

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Supply Chain, Healthcare Administration, or a related field; equivalent experience may be considered
3–5 years of relevant experience in regulatory affairs, quality assurance, pharmaceutical distribution, healthcare compliance, pharmaceutical manufacturing, or a related regulated environment
Experience interpreting regulatory, quality, manufacturer, or customer requirements and translating them into operational controls
Experience supporting pharmaceutical distribution, specialty pharmacy, wholesale distribution, manufacturer, or 3PL operations
Experience investigating complex issues, documenting risk‑based decisions, and coordinating corrective actions across functions
Experience supporting REMS products, restricted‑distribution programs, specialty pharmaceuticals, biologics, cell and gene therapies, or other complex therapies
Knowledge of DEA controlled substance regulations and state board of pharmacy requirements
Familiarity with cold‑chain, ultra‑low‑temperature, chain‑of‑custody, or specialty logistics requirements
Experience with product commercialization, launch readiness, regulatory change implementation, or manufacturer program onboarding
Experience interacting with pharmaceutical manufacturers, auditors, regulatory agencies, program administrators, or external business partners
Regulatory Affairs Certification (RAC), pharmacy technician certification, or a comparable professional credential
Strong working knowledge of pharmaceutical regulatory compliance and specialized distribution controls
Ability to interpret overlapping regulatory, manufacturer, quality, licensing, and operational requirements
Ability to distinguish legal requirements, regulatory…