Regulatory Compliance Specialist

The Regulatory Compliance Specialist ensures that all operations within Langham Logistics environment comply with applicable regulatory requirements, industry standards, and client expectations. This role is critical in managing compliance for both temperature-sensitive biologics, raw materials, and vaccines as well as general pharmaceutical products, maintaining integrity across storage, handling, and distribution processes.

The Regulatory Compliance Specialist serves as a key liaison with internal teams, clients, and regulatory authorities to ensure continuous adherence to cGMP, GDP, FDA, and other relevant regulations.

Key Outcomes Expected

• 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.

Education and Experience

• 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.
• Experience with cold chain logistics for biologics and vaccines preferred.
• 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 Skills:

• 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.

Physical Demands

• Physical movements including bending, stooping, and lifting up to 75 pounds as part of daily work routine.
• May be working on concrete in a warehouse environment (subject to heat and cold).
• Must be able to operate computer equipment.

Work Environment

This role operates in a regulated warehouse and office environment, including areas requiring temperature-controlled storage. Occasional travel may be required for audits, training, or client engagements.

Disclaimer

This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve.

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