Pharma Materials & Controlled Substances Specialist

Jobtailor; Melrose Park (IL); On-site; USD 60,000 - 90,000; Full time

Job summary

Jobtailor seeks a Regulatory and Materials Coordinator to oversee receipt, storage, and disposal of pharmaceutical materials, ensuring compliance and audit readiness. You will manage reference standards, and coordinate with Quality, Regulatory Affairs, and Supply Chain to maintain accurate records and shipping compliance.

Responsibilities include regulatory submissions, DEA registrations, and collaboration with cross-functional teams to ensure smooth operations and inspection readiness.

Qualifications

• Bachelor’s degree in Science, Chemistry, Supply Chain, or related field
• 2+ years of experience
• Controlled substance recordkeeping and reporting experience
• Proficiency in Microsoft Office applications
• Strong organizational, communication, and documentation skills
• Strong understanding of regulatory and compliance requirements related to pharmaceutical materials and controlled substances
• Ability to effectively speak, read, write, and understand English
• Certification in DOT and IATA shipping procedures preferred

Responsibilities

• Oversee receipt, quarantine, release, storage, dispensing, transfer, shipment, inventory control, and disposal of raw materials, APIs, excipients, reference standards, RLD materials, and other regulated materials
• Support material lifecycle activities including sampling, testing, inventory management, inter-site transfers, domestic and international shipments, hazardous material transportation, customs clearance, and material availability
• Administer reference standard, reserve sample, and retention sample management programs
• Manage controlled substance inventories, dispensing, reconciliation, recordkeeping, reporting, destruction activities, and physical security controls
• Maintain DEA registrations and state licenses, coordinate regulatory submissions, support inspections and audits, and maintain inspection-ready documentation
• Create, review, implement, and improve procedures, records, training, and operational controls
• Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, Legal, Corporate Services, suppliers, laboratories, and regulatory agencies
• Perform additional responsibilities and special projects as assigned

Skills

Inventory Control

Regulatory Compliance

Documentation

Quality Assurance

Cross-functional Collaboration

Effective Communication

Education

Bachelor’s degree in Science, Chemistry, Supply Chain, or related field

Tools

Microsoft Office

Job description

Jobtailor seeks a Regulatory and Materials Coordinator to oversee receipt, storage, and disposal of pharmaceutical materials, ensuring compliance and audit readiness. You will manage reference standards, and coordinate with Quality, Regulatory Affairs, and Supply Chain to maintain accurate records and shipping compliance.

Responsibilities include regulatory submissions, DEA registrations, and collaboration with cross-functional teams to ensure smooth operations and inspection readiness.