Associate Director, CMC Regulatory Quality

Regeneron Pharmaceuticals Inc.; City of Rensselaer (NY); On-site; USD 148,000 - 241,000; Full time

Job summary

Regeneron Pharmaceuticals Inc. seeks an Associate Director, Quality Compliance, CMC Regulatory Affairs to lead quality compliance across the CMC Regulatory Affairs program in an onsite role at the Rensselaer site.

You will guide regulatory impact assessments, strengthen alignment between quality and regulatory activities, and drive CAPA ownership and inspection readiness. Collaborate with CMC strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners to translate

Qualifications

• Bachelor's degree in chemistry, biology, or a related discipline.
• 10+ years in biotechnology or pharmaceutical industry.
• Minimum 5 years in CMC Regulatory Affairs or Quality.
• Experience with regulatory impact assessments and QMS.
• Experience managing direct reports.

Responsibilities

• Lead the Quality Compliance group within CMC Regulatory Affairs.
• Provide leadership across the broader CMC Regulatory Affairs organization.
• Champion regulatory impact assessments and regulatory positions.
• Assess changes and deviations within Operation's Quality Management System (QMS).
• Drive CAPA ownership and closure.
• Represent Quality Compliance at regulatory, infrastructure, and cross-functional meetings.
• Lead process improvements, performance monitoring, and inspection readiness initiatives.
• Build alignment across teams and translate complex issues into clear decisions.

Skills

Leadership

Regulatory affairs

Quality compliance

QMS experience

Stakeholder communication

Change management

Impact assessments

People management

Education

Bachelor's degree in chemistry, biology, or related discipline

Job description

Regeneron Pharmaceuticals Inc. seeks an Associate Director, Quality Compliance, CMC Regulatory Affairs to lead quality compliance across the CMC Regulatory Affairs program in an onsite role at the Rensselaer site.

You will guide regulatory impact assessments, strengthen alignment between quality and regulatory activities, and drive CAPA ownership and inspection readiness. Collaborate with CMC strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners to translate