Associate Director CMC Regulatory Affairs - Quality Compliance - Quality Compliance
Regeneron Pharmaceuticals
Summary
We are seeking an Associate Director, Quality Compliance, CMC Regulatory Affairs to join our CMC Regulatory Affairs team, supporting our manufacturing and supply business area in an onsite work model. In this role, you will provide strategic quality compliance leadership, guide regulatory impact assessments, and strengthen organizational alignment across quality and regulatory activities while collaborating with CMC Regulatory Affairs strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners.
Job description
Discover your role
- 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 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.
This role requires
- 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.
- Experience with Quality Management Systems and regulatory impact assessments.
- 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.
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
- Experience with Quality Management Systems and regulatory impact assessments
- 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
- Annual Bonuses
- Incentive Plans
- Equity Awards
- Pension/Retirement Benefits
- 401(k) Matching
- Health & Wellness Programs
- Fitness Centers
- Medical, Dental & Vision
- Life & Disability Insurance
- Paid Time Off
- Family Support Benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.