Associate Director CMC Regulatory Affairs - Quality Compliance - Quality Compliance

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 148,000 - 241,000; Full time

Job summary

Regeneron Pharmaceuticals in the United States is seeking an Associate Director of Quality Compliance within CMC Regulatory Affairs to lead the Quality Compliance group onsite in Rensselaer. You will guide regulatory impact assessments, shape regulatory positions, and align quality/regulatory activities across teams globally.

The role requires a chemistry/biology background with 10+ years in biotech/pharma and at least 5 years in CMC Regulatory Affairs or Quality, plus QMS experience.

Qualifications

• 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.

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.
• You build alignment across teams and translate complex issues into clear decisions.

Skills

Leadership

Regulatory Affairs

Quality Management

QMS

Stakeholder Communication

People Management

Cross-functional Collaboration

Process Improvement

Education

Bachelor’s degree in Chemistry/Biology

Job description

Build our future together:

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.
• 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.
• You 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.

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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.

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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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.

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

Salary Range (annually)

$147,800.00 - $241,200.00