Compliance Specialist, External Manufacturing

Regeneron Pharmaceuticals • Valley, AL

1d • $62,355 - $128,700 • Onsite

About The Position

The Compliance Specialist supports operations and compliance activities for the manufacturing of Regeneron products within the External Manufacturing team. The role focuses on managing quality-related processes, maintaining documentation, supporting inspection and audit readiness, and ensuring Drug Product Manufacturing records meet established quality standards, policies, and procedures. The position is based in East Greenbush, New York, with a Monday–Friday schedule from 8:00 a.m. to 4:30 p.m. The level (Associate Specialist, Specialist, or Senior Specialist) will be determined based on experience.

Requirements

• Bachelor of Science or Bachelor of Arts degree in a scientific field.
• Related experience in cGMP manufacturing operations (clinical and/or commercial): 0–2 years for Associate Specialist, 2+ years for Specialist, or 5+ years for Senior Specialist; level will be determined based on experience.
• Knowledge of drug product manufacturing from formulation through final package.
• Basic knowledge of regulatory compliance, including cGMP and FDA regulations, and familiarity with ICH guidelines and EU regulations.
• Proficiency in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word, or similar tools, and experience working within shared work environments.
• Strong interpersonal, written, and oral communication skills, with an emphasis on technical writing.
• Confidence, high emotional intelligence, and strong communication skills for providing team updates.
• Resilience and flexibility when facing challenges and adversarial situations.
• Ability to understand and listen to team members’ and stakeholders’ needs while supporting productive team environments toward a common objective.

Nice To Haves

• Experience collaborating with CMOs/CROs.

Responsibilities

• Lead and manage change controls, SCARs, SCNs, NPCs, and CAPAs.
• Review and maintain procedures, policies, and other instructional documents, with a focus on continuous improvement.
• Maintain knowledge of current good manufacturing practices (cGMPs).
• Support internal and external inspection and audit readiness activities.
• Conduct periodic reviews of Drug Product Manufacturing documentation and records to assess compliance with established quality standards, policies, and procedures.
• Maintain required training status on Regeneron-specific work instructions and SOPs.
• Implement continuous process improvements.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level