Compliance Specialist, External Manufacturing

About the Role

Regeneron is seeking a Compliance Specialist within the External Manufacturing team. This role is responsible for operations support and compliance-related activities for the manufacturing of Regeneron products.

• Location: East Greenbush, New York, United States
• Work Schedule: Monday-Friday, 8am-4:30pm

Key Responsibilities

• Lead and manage change controls, SCARs, SCN’s, 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 both internal and external inspection and audit readiness activities.
• Responsible for 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.
• Continuous process improvement implementation.

Requirements & Tech Stack

• BS/BA in a scientific field.
• Knowledge of drug product manufacturing from formulation through the final package.
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficient in Veeva, Opstrakker, Excel, PowerPoint, Visio, Word.
• Experience working within shared work environments.
• Strong interpersonal, written and oral communication skills, with an emphasis on technical writing.
• Exhibits confidence, has a high emotional IQ, and strong interpersonal, written and oral communication skills for providing team updates.
• Shows resiliency and flexibility in the face of challenges and adversarial situations.
• Understands and listens to team members and stakeholders' needs while supporting productive team environments toward a common objective.
• Experience in collaborating with CMOs/CROs is preferred.

The level of the position (Associate Specialist, Specialist, Sr Specialist) will be determined based on the candidate's experience.