Regulatory Affairs Specialist

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 expectations, contractual commitments, and internal best practices Strong analytical, investigative, technical‑writing, documentation, and problem‑solving skills Ability to perform risk assessments, identify control gaps, and recommend mitigation actions Excellent written and verbal communication skills Ability to manage multiple priorities, lead workstreams, drive follow‑up, and influence stakeholders without direct authority Proficiency with compliance systems, document management tools, investigation records, metrics, and Microsoft Office applications Core Competencies Demonstrates expertise in regulatory affairs, compliance, and quality assurance within the pharmaceutical industry, with a strong focus on managing complex therapies and specialized distribution programs. Proficient in translating regulatory requirements into operational controls and conducting thorough risk assessments. Highest-signal resume keywords Regulatory Affairs Certification (RAC) Pharmaceutical Regulatory Compliance REMS Products Support Controlled Substance Regulations Knowledge Analytical and Problem‑Solving Skills ATS Optimization Keywords Hard Skills Regulatory Affairs Quality Assurance Pharmaceutical Distribution Risk Assessment Operational Controls Compliance Documentation Investigative Skills Technical Writing Specialty Pharmaceuticals Biologics and Gene Therapies Soft Skills Excellent Communication Skills Stakeholder Influence Problem‑Solving Analytical Thinking Multi‑Priority Management Certifications & Qualifications Regulatory Affairs Certification (RAC) Pharmacy Technician Certification Industry Keywords FDA Regulations DEA Regulations Cold‑Chain Logistics Specialty Pharmacy 3PL Operations Quality Standards Pharmaceutical Manufacturing Client Onboarding Audit Support Risk‑Based Decision Making Tools & Technologies Compliance Systems Document Management Tools Microsoft Office Applications #J-18808-Ljbffr Jobtailor