Document Control and Regulatory Specialist

Langham Logistics, Inc • Indianapolis, IN

20d

About The Position

The Document Control and Regulatory Specialist contributes to Langham Logistics' goals of exceptional customer service, quality, process improvement, and profitability by managing the document control system and supporting regulatory compliance activities across the organization. This role ensures regulatory, quality, and operational documents are properly created, reviewed, approved, maintained, distributed, and archived in accordance with applicable requirements.

This position supports compliance across pharmaceutical logistics operations, including temperature-sensitive biologics, raw materials, vaccines and general pharmaceutical products, helping maintain audit readiness and alignment with cGMP, GDP, FDA, ICH and client requirements.

Requirements

• Bachelor's degree in Life Sciences, Quality Management, Regulatory Affairs, Pharmacy, or a related field preferred.
• 3-5 years of experience in document control, quality systems, and/or regulatory compliance within pharmaceutical, biotech, or 3PL logistics environments.
• Strong knowledge of cGMP, GDP, FDA, ICH, and related pharmaceutical or logistics regulatory requirements.
• Experience with document management systems and/or QMS software.
• Proven ability to interpret and apply regulatory and quality requirements to warehouse, storage, and distribution operations.
• Strong organizational, communication, and problem-solving skills.
• Proficiency with MS Office applications.

Nice To Haves

• Experience with cold chain logistics for biologics and vaccines.
• Familiarity with ISO standards such as ISO 9001 and ISO 13485, and other applicable quality frameworks.
• Experience supporting internal audits, client audits, regulatory inspections, and client regulatory requests or submissions.
• Familiarity with temperature-sensitive product handling, validation protocols, risk management, and vendor compliance processes.

Responsibilities

• Manage the creation, revision, review, approval, issuance, distribution, and archival of controlled documents, including SOPs, work instructions, policies, forms, and quality agreements.
• Maintain the document control system to ensure documents are current, properly versioned, retrievable, and accessible to authorized personnel.
• Monitor document review cycles, periodic reviews, and expiration timelines to ensure timely updates and continued compliance.
• Support implementation and maintenance of Quality Management System (QMS) procedures related to document control and regulatory compliance.
• Ensure compliance with applicable federal, state, international, and client-specific requirements, including cGMP, GDP, FDA, ICH, and other relevant pharmaceutical logistics regulations.
• Conduct regulatory research and monitor changes in regulations, guidance, or industry practices that may affect storage, handling, distribution, documentation, or quality systems.
• Collaborate with quality, operations, warehouse, and cross-functional teams to develop, revise, format, and maintain documents and processes that support compliant operations.
• Support internal audits, client audits, and regulatory inspections by providing complete, accurate, and readily retrievable documentation and by assisting with CAPA follow-up activities as needed.
• Evaluate and support approval of regulatory and quality documentation related to new products, shipping procedures, vendor compliance, and operational changes.
• Maintain records, logs, reporting, and metrics to support audit readiness, management review, and continuous improvement initiatives.
• Provide guidance and training to associates on document control procedures, regulatory requirements, and compliance practices.
• Maintain proper retention, archival, and retrieval practices for historical, quality, and regulatory records and support continuous improvement of document control and compliance programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level