Document Control and Regulatory Specialist

Job overview

The Document Control and Regulatory Specialist role is onsite in Indianapolis, IN, primarily office-based with regular interaction in a regulated warehouse environment. Compensation is not specified. The role supports Langham Logistics’ pharmaceutical logistics operations, including temperature-sensitive biologics, vaccines, raw materials, and other pharmaceutical products. The specialist maintains controlled documents and supports regulatory compliance, audit readiness, and quality systems. This work helps ensure storage, handling, and distribution operations meet applicable regulatory, quality, and client requirements.

What you'll do

• Manage creation, revision, review, approval, distribution, and archiving of controlled documents
• maintain document versions and review cycles
• support QMS procedures
• monitor regulatory changes
• collaborate with quality, operations, warehouse, and cross-functional teams
• support audits, inspections, and CAPA follow-up as needed
• maintain records and metrics
• provide guidance and training on document control and compliance.

What we're looking for

Skills & competencies

document control

regulatory compliance

indianapolis in

langham logistics

full-time

pharmaceutical logistics

cgmp

gdp

fda

ich

qms

audit readiness

cold chain logistics preferred

occasional travel may be required

Work arrangement

• Weekend coverage required

Why this role

Requires 3–5 years of relevant experience and strong knowledge of cGMP, GDP, FDA, and ICH requirements; occasional travel may be required for audits, training, inspections, or client meetings.

About the employer

Langham Logistics is hiring for this role. Industry: Other Warehousing and Storage. Sector: 49.