Compliance Specialist, External Manufacturing

Regeneron seeks a Compliance Specialist to support external manufacturing operations and ensure adherence to cGMP standards. The role manages regulatory documentation, change controls, audit readiness, and process improvements for drug product manufacturing.

Responsibilities

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs
• Review and maintain manufacturing procedures, policies, and instructional documents
• Support internal and external inspection and audit readiness activities
• Conduct periodic reviews of drug product manufacturing documentation for compliance
• Implement continuous process improvement initiatives

Requirements

• Bachelor's degree in scientific field
• 0-5+ years cGMP manufacturing operations experience (level-dependent)
• Knowledge of drug product manufacturing from formulation through packaging
• Proficiency in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word
• Strong technical writing and oral communication skills
• Understanding of cGMP, FDA regulations, ICH and EU regulatory frameworks
• Experience collaborating with CMOs/CROs (preferred)

Compensation: $62,355-$128,700 annually