Associate Director, Regulatory Compliance

Job Summary

To drive regulatory compliance and intelligence initiatives, the full-time Associate Director, Regulatory Compliance will execute an enterprise regulatory intelligence program, maintain governance documentation, and lead inspection readiness activities across multiple manufacturing sites.

Key responsibilities

• Execute the regulatory intelligence and surveillance program, monitoring global regulations and updating procedures accordingly
• Conduct regulatory change impact assessments and maintain a library of regulatory deliverables to ensure enterprise-wide readiness
• Lead inspection readiness activities and serve as the primary subject matter expert during Health Authority inspections and agency engagements

Required qualifications

• B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or a related scientific discipline
• Minimum of 14 years of relevant experience in sterility assurance and contamination control within a biopharmaceutical environment
• Extensive experience engaging with global Health Authorities during site inspections and regulatory filings
• Demonstrated expertise in developing enterprise-level governance frameworks and quality standards
• Supervisory experience leading cross-functional or compliance-focused teams