Compliance Specialist I

Position Summary
The 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 Position
This 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 & Responsibilities

• Serve as the primary site liaison for all Texas DSHS and DEA licensing activities, including new applications, renewals, amendments, and ongoing regulatory correspondence
• Support 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 standards
• Generate 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 execution
• Maintain 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 requests
• Assist with reconciliation of controlled substance movements, including receipt, storage, dispensing, returns, and destruction
• Create and maintain item codes for clinical supply inventory within ERP or inventory management systems, ensuring accuracy of product attributes, regulatory classifications, and study-specific identifiers
• Review inbound shipment documentation for completeness and compliance prior to arrival
• Maintain audit-ready documentation in accordance with QMS and GxP requirements
• Meet established timelines and SLAs for completion of all assigned activities
• Protect the safety and integrity of company and client information in accordance with confidentiality and data protection policies
• Complete required training, including SOPs and Work Instructions, within documented timeframes
• Perform other duties as assigned in alignment with evolving business needs

Qualifications

• Bachelor’s degree in Life Sciences, Supply Chain, Regulatory Affairs, or related field preferred
• 2–5 years of experience in clinical supply chain, pharmaceutical operations, or regulated industry compliance
• Working knowledge of DEA regulations, ARCOS reporting, and controlled substance handling requirements
• Familiarity with 21 CFR regulations, GMP, and GDP standards
• Experience with ERP systems and inventory/master data management tools
• Strong attention to detail and documentation accuracy

Skills & Competencies

• Strong understanding of regulatory compliance frameworks in pharmaceutical or clinical supply environments
• High level of accuracy in data review, reconciliation, and documentation control
• Ability to manage multiple compliance workflows simultaneously
• Strong analytical and problem-solving skills
• Effective communication and cross-functional collaboration skills
• Ability to work under deadlines in a highly regulated environment
• Commitment to quality, compliance, and audit readiness

Preferred Experience

• Clinical trial supply chain operations
• Controlled substance logistics and compliance programs
• Import/export compliance and customs coordination
• DEA licensing and regulatory reporting experience
• Labeling systems, artwork review, or regulatory labeling operations