Associate Director CMC Regulatory Affairs - Quality Compliance
$147.8k - $241.2kRegeneron Pharmaceuticals, Inc.
Associate Director position in CMC Regulatory Affairs at Regeneron supporting manufacturing and supply operations. This role provides strategic quality compliance leadership, manages regulatory impact assessments, and strengthens alignment across quality and regulatory functions in an onsite setting.
Responsibilities
- Support management of the Quality Compliance group and provide leadership across CMC Regulatory Affairs organization
- Champion regulatory impact assessments and regulatory positions across teams
- Assess changes and deviations within the Quality Management System and drive Corrective and Preventive Action plan closure
- Lead process improvements, performance monitoring, and inspection readiness initiatives
- Represent Quality Compliance at regulatory, infrastructure, and cross-functional meetings
Requirements
- Bachelor's degree in chemistry, biology, or related discipline
- 10+ years biotechnology or pharmaceutical industry experience
- 5+ years CMC Regulatory Affairs or Quality experience
- Quality Management Systems and regulatory impact assessment expertise
- Experience managing direct reports and leading teams
- Ability to analyze complex information and communicate recommendations
- Cross-functional collaboration and stakeholder presentation skills
Vacancy posted 4 days ago
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