CMC Quality Compliance Lead, Regulatory Strategy

Regeneron Pharmaceuticals, Inc.; United States; Vor Ort; USD 148.000 - 241.000; Vollzeit

Benefits dieser Stelle

Annual bonus and incentive plans

Equity awards

Pension or retirement benefits

Health and wellness programs

Paid time off

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director of Quality Compliance, CMC Regulatory Affairs to lead the Quality Compliance group within the CMC Regulatory Affairs organization.

This onsite role collaborates with global manufacturing and supply partners and strategy teams to strengthen regulatory alignment and drive CAPA ownership. The position requires a Bachelor’s degree in a related field and 10+ years in biotech/pharma, including 5+ years in CMC Regulatory Affairs or

Qualifikationen

• Bachelor’s degree in chemistry, biology, or related discipline.
• 10+ years of experience in biotechnology or pharmaceutical industries.
• Minimum 5 years in CMC Regulatory Affairs or Quality.
• Experience with Quality Management Systems and regulatory assessments.
• CMC regulatory experience with Quality Management System exposure is a plus.
• Experience managing direct reports and leading teams.

Aufgaben

• Support management of the Quality Compliance group.
• Provide leadership across the broader CMC Regulatory Affairs organization.
• Champion consistent regulatory impact assessments and regulatory positions.
• Assess changes and deviations within the IOPS Quality Management System.
• Drive and support CAPA plan ownership and closure.
• Represent Quality Compliance at regulatory, infrastructure, and cross-functional meetings.
• Lead process improvements, performance monitoring, and inspection readiness initiatives.
• Translate complex issues into clear decisions across teams.

Kenntnisse

Leadership

Regulatory affairs

Quality management

Cross-functional collaboration

Regulatory impact assessments

Ausbildung

Bachelor’s degree in chemistry, biology, or related

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director of Quality Compliance, CMC Regulatory Affairs to lead the Quality Compliance group within the CMC Regulatory Affairs organization.

This onsite role collaborates with global manufacturing and supply partners and strategy teams to strengthen regulatory alignment and drive CAPA ownership. The position requires a Bachelor’s degree in a related field and 10+ years in biotech/pharma, including 5+ years in CMC Regulatory Affairs or