Associate Director CMC Regulatory Affairs - Quality Compliance

About the role

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. This position supports the CMC Regulatory Affairs team within the manufacturing and supply business area in an onsite work model based in Rensselaer. The Associate Director, Quality Compliance, CMC Regulatory Affairs provides strategic quality compliance leadership, guides regulatory impact assessments, and strengthens organizational alignment across quality and regulatory activities while collaborating with CMC Regulatory Affairs strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners.

Responsibilities

• 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 Operations' Quality Management System (QMS)
• Drive and support Corrective and Preventive Action plan 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

Requirements

• Bachelor's degree in chemistry, biology, or a related discipline
• 10+ years of experience in the biotechnology or pharmaceutical industry
• Minimum 5 years of experience in CMC Regulatory Affairs or Quality
• Significant experience conducting regulatory impact assessments and utilizing Quality Management Systems (QMS)
• CMC regulatory experience combined with Quality Management System experience is an advantage
• Experience managing direct reports and leading teams
• Ability to analyze complex information and communicate clear recommendations
• Experience presenting complex regulatory or quality compliance matters to stakeholders
• Ability to collaborate across cross-functional teams and build positive relationships
• Ability to work effectively in ambiguous environments with minimal direction
• Openness to change and a continuous process improvement mindset

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Pay

Salary Range (annually, Canada): $147,800.00 - $241,200.00. The final offer will be determined within the relevant range based on the country of employment, specific role level, and skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Schedule

Location: Rensselaer. Work model: Onsite. Many roles at Regeneron are required to be performed onsite; speak with your recruiter and hiring manager for more information about onsite expectations for this role and location.