Associate Director CMC Regulatory Affairs - Quality Compliance

BioSpace; City of Rensselaer (NY); On-site; USD 148,000 - 241,000; Full time

Job summary

Regeneron seeks an Associate Director, Quality Compliance, CMC Regulatory Affairs to lead quality compliance for our CMC programs. This onsite role requires strategic oversight, regulatory impact assessments, and cross-functional collaboration with global manufacturing teams.

You will guide regulatory positions, manage CAPA, and drive improvements ensuring inspection readiness and alignment across Quality and Regulatory functions.

Qualifications

• Bachelor's degree required 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.
• CMC regulatory experience plus QMS is an advantage.
• Experience leading teams and direct reports.
• Strong analytical and communication skills.

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 Operation's Quality Management System (QMS).
• Drive and support CAPA 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.

Skills

Regulatory leadership

Quality management

Cross-functional collaboration

People management

Regulatory impact assessments

Education

Bachelor's degree in Chemistry, Biology, or related

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

Location: Rensselaer

Work model: Onsite

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.
• Assessing changes and deviations within Operation's 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.
• You build alignment across teams and translate complex issues into clear decisions.

This Role Requires

• Bachelors 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.

Equal Opportunity and Diversity Statement

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Background Checks

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Location Specific Note

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$147,800.00 - $241,200.00