Regulatory Compliance Manager

Job Summary

Providing critical support for regulatory compliance activities, the full-time Regulatory Compliance Manager will manage SOP maintenance, lead inspection readiness activities, and collaborate with cross-functional teams while working remotely.

Key responsibilities

• Manage SOP revisions and maintain compliance documentation, ensuring timely updates and stakeholder engagement
• Lead inspection readiness efforts, including managing the inspection calendar and supporting audit activities
• Analyze compliance metrics and trends, providing recommendations and monthly reports to leadership

Required qualifications

• Bachelor's degree in life sciences, scientific, or engineering field
• 4+ years of general regulatory affairs experience and knowledge of the drug development process
• 3 years of audit and inspection experience
• Familiarity with electronic document management systems (EDMS)
• Prior experience in the pharmaceutical and/or healthcare industry is preferred