Compliance Specialist

Who Are WeFor nearly 30 years, CalCog has been dedicated to supporting the R&D supply chain. As a global company, our services include clinical packaging design, clinical packaging and labelling, global storage and distribution, commercial and ancillary product procurement, and medical product supply management to support post-trial and early access programs. If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.Position SummaryThe Compliance Specialist is responsible for supporting regulatory, licensing, and operational compliance across clinical supply chain activities. This role ensures adherence to federal and state regulatory requirements, including DEA and Texas DSHS licensing, controlled substance compliance (including ARCOS reporting), Importer of Record (IOR) management for U.S. inbound shipments, label text compliance under 21 CFR regulations, and inventory governance within ERP systems.Organizational PositionThis post holder reports directly to the VP of Operations, or designee, but theywill work closely with CalCog’s Quality, Operations, Client Services, and Commercial teams.Roles & ResponsibilitiesServe as the primary site liaison for all Texas DSHS and DEA licensing activities, including new applications, renewals, amendments, and ongoing regulatory correspondenceSupport label text review by verifying accuracy and completeness of required label elements in compliance with 21 CFR Part 312 and 21 CFR Part 201, approved regulatory documentation, study protocols, and internal labeling standardsGenerate and maintain Importer of Record (IOR) documentation for U.S. inbound clinical supply shipments, provide formal import greenlight authorization upon satisfaction of all compliance requirements, and coordinate with customs brokers to facilitate import executionMaintain accurate, real-time controlled substance inventory records, including oversight of DEA ARCOS (Automation of Reports and Consolidated Orders System) submissions, quota reporting, and related regulatory requestsAssist with reconciliation of controlled substance movements, including receipt, storage, dispensing, returns, and destructionCreate and maintain item codes for clinical supply inventory within ERP or inventory management systems, ensuring accuracy of product attributes, regulatory classifications, and study-specific identifiersReview inbound shipment documentation for completeness and compliance prior to arrivalMaintain audit-ready documentation in accordance with QMS and GxP requirementsMeet established timelines and SLAs for completion of all assigned activitiesProtect the safety and integrity of company and client information in accordance with confidentiality and data protection policiesComplete required training, including SOPs and Work Instructions, within documented timeframesPerform other duties as assigned in alignment with evolving business needsQualificationsBachelor’s degree in Life Sciences, Supply Chain, Regulatory Affairs, or related field preferred2–5 years of experience in clinical supply chain, pharmaceutical operations, or regulated industry complianceWorking knowledge of DEA regulations, ARCOS reporting, and controlled substance handling requirementsFamiliarity with 21 CFR regulations, GMP, and GDP standardsExperience with ERP systems and inventory/master data management toolsStrong attention to detail and documentation accuracySkills & CompetenciesStrong understanding of regulatory compliance frameworks in pharmaceutical or clinical supply environmentsHigh level of accuracy in data review, reconciliation, and documentation controlAbility to manage multiple compliance workflows simultaneouslyStrong analytical and problem-solving skillsEffective communication and cross-functional collaboration skillsAbility to work under deadlines in a highly regulated environmentCommitment to quality, compliance, and audit readinessPreferred ExperienceClinical trial supply chain operationsControlled substance logistics and compliance programsImport/export compliance and customs coordinationDEA licensing and regulatory reporting experienceLabeling systems, artwork review, or regulatory labeling operations Job Category: RegulatoryJob Type: Full TimeJob Location: Hybrid - Bastrop TX