Risk Meets Resilience: How Cybersecurity Strengthened Regeneron’s Manufacturing Division

In the high-stakes world of biotech, even minor cybersecurity vulnerabilities can disrupt life-saving drug production. At Regeneron, Amy Bittle joined the IOPS division to secure critical systems, enhance regulatory posture, and prepare the organization for global audits across the Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The Challenge

Industrial Operations and Product Supply (IOPS) manages biologics manufacturing for Regeneron, requiring absolute alignment with GMP, HIPAA, and 21 CFR Part 11. Internal systems lacked cohesive security governance and centralized risk oversight.

The Approach

Amy led comprehensive risk assessments for internal systems, designed phishing simulations and employee awareness training, and implemented policy updates to meet GxP, GAMP, and EMA guidelines. She supported health authority audits, strengthened incident response plans, and drove executive risk reporting.

The Impact

Improved audit-readiness for multiple regulatory frameworks (FDA, EMA, HIPAA) Reduced risk exposure across manufacturing systems Established repeatable controls for incident response, policy compliance, and vendor oversight

The Breakdown: