Langham Logistics · 2 months ago
Regulatory Compliance Specialist
Indianapolis, IN
Full-time
Onsite
Mid, Senior Level
3+ years expLangham Logistics is a company focused on ensuring compliance within the pharmaceutical logistics sector. The Regulatory Compliance Specialist is responsible for managing compliance with regulatory requirements and industry standards for temperature-sensitive biologics, raw materials, and vaccines, while serving as a liaison with internal teams and regulatory authorities.
AutomotiveTransportation
Responsibilities
Monitor and ensure compliance with federal, state, and international regulations governing pharmaceutical logistics, including cold chain requirements for biologics and vaccines
Support implementation and maintenance of Quality Management System (QMS) procedures related to regulatory compliance
Review, develop, and maintain SOPs, policies, and quality agreements to ensure regulatory alignment
Conduct regulatory research to identify changes in laws, guidelines, or industry best practices affecting pharmaceutical storage and distribution
Collaborate with operations, warehouse, and quality teams to ensure compliance with GDP, cGMP, and temperature-controlled logistics standards
Assist in internal audits, client audits, and regulatory inspections; track corrective and preventive actions (CAPA) as needed
Evaluate and approve regulatory documentation for new products, shipping procedures, and vendor compliance
Provide guidance and training to associates on regulatory requirements and compliance practices
Maintain up-to-date records and reporting to support audit readiness and regulatory submissions
Support continuous improvement initiatives related to regulatory processes and compliance programs
Qualification
Required
Bachelor's degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field
3–5+ years of experience in regulatory compliance within pharmaceutical, biotech, or 3PL logistics environments
Strong knowledge of cGMP, GDP, FDA, ICH, and other relevant pharmaceutical regulations
Proven ability to interpret and apply regulations to warehouse and distribution operations
Excellent organizational, communication, and problem-solving skills
Proficiency with QMS software and MS Office applications
Preferred
Experience with cold chain logistics for biologics and vaccines preferred
Experience managing regulatory audits and inspections for both general pharmaceuticals and biologics
Knowledge of ISO standards or other quality frameworks applicable to pharmaceutical logistics
Familiarity with temperature-sensitive product handling, validation protocols, and risk management
Prior experience supporting client regulatory requests or submissions
Company
Langham Logistics
Langham Logistics is a logistics company offering supply chain management services.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tracy Jaisle
Chief Financial Officer
Brian Landrum
Chief Operating Officer
Recent News
Indianapolis Business Journal
2023-12-26
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