Associate Director CMC Regulatory Affairs - Quality Compliance - Quality Compliance
About The Position
Regeneron is seeking an Associate Director, Quality Compliance, CMC Regulatory Affairs to join its CMC Regulatory Affairs team and support the manufacturing and supply business area. This onsite role in Rensselaer provides strategic quality compliance leadership, guides regulatory impact assessments, and strengthens alignment across quality and regulatory activities. The role collaborates with CMC Regulatory Affairs strategy teams, Quality Compliance colleagues, and global manufacturing and supply partners. It also supports management of the Quality Compliance group and provides leadership across the broader CMC Regulatory Affairs organization.
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.
Nice To Haves
- CMC regulatory experience combined with Quality Management System experience is an advantage.
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 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.
Benefits
- Annual bonuses or other incentive plans may be offered, depending on country and role.
- Equity awards may be offered, depending on country and role.
- Pension or retirement benefits may be offered, depending on country and role.
- 401(k) company match may be offered, depending on country and role.
- Health and wellness programs may be offered, depending on country and role.
- Fitness centers may be available, depending on country and role.
- Insurance benefits, including medical, dental, vision, life, and disability coverage, may be offered, depending on country and role.
- Paid time off may be offered, depending on country and role.
- Family support benefits may be offered, depending on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
