Global Serialization & Launch Project Lead

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) in East Greenbush, NY seeks a Project Specialist to drive compliant global product launches within External Manufacturing Serialization. You will coordinate labeling attributes, GS1 identifiers, and master data with CMOs/3PLs, while managing validations and quality events under QMS.

This on-site role requires DSCSA/EU-FMD knowledge and hands-on Tracelink experience. The position involves cross-functional collaboration, change control ownership, and tracking

Qualifications

• BS/BA in Engineering, Supply Chain, or Life Sciences.
• 0–2 years: Associate Specialist; 2+ years: Specialist; 5+ years: Sr Specialist; level based on experience.
• Hands-on experience with track-and-trace systems (Tracelink) and partner connectivity.
• Experience supporting investigations and quality events (deviations, EOEs, CCs, CAPAs).
• Demonstrate project management skills.
• Experience leading end-to-end serialization implementations and product launches; strong knowledge of DSCSA, EU-FMD, and ROW requirements.

Responsibilities

• Ensure serialization readiness for new and transferred products, including market-specific DSCSA, EU-FMD, and ROW requirements.
• Coordinate labeling, GTINs/SSCCs, aggregation strategies, and master data alignment with CMOs/3PLs.
• Complete readiness checks, input-output qualification runs, and planning with Project Managers.
• Support investigations and documentation for validations, deviations, nonconformances, complaints, EOEs, CCs, and CAPAs.
• Maintain audit-ready records and ensure timely closure per internal QMS and regulatory standards.
• Implement corrective actions, risk assessments, and mitigation plans.
• Operate and coordinate track-and-trace platforms (e.g., Tracelink): user access, master data, partner connections, EPCIS/EDI monitoring, exception handling.
• Troubleshoot data flow issues to minimize supply disruptions.
• Plan and implement CSV activities (IQ/OQ/PQ) for serialization systems and integrations.
• Support technical transfers by aligning serialization requirements, artwork changes, and site configurations.
• Own change controls and configuration baselines across systems and partners.
• Liaise with CMOs, 3PLs, and EMVOs to resolve serialization issues and maintain required operations.
• Communicate timelines, risks, and results; drive cross-functional alignment with Supply Chain PMs.
• Apply PM techniques to scope, schedule, and deliver EM sub-projects.
• Track progress and report status to ensure timely execution.

Skills

Track-and-trace systems experience (Tr

Project management

Serialization/DSCSA knowledge

Quality events investigations support

Education

BS/BA in Engineering, Supply Chain, or Life Sciences

Tools

Tracelink platform

Job description

Regeneron Pharmaceuticals, Inc (USA) in East Greenbush, NY seeks a Project Specialist to drive compliant global product launches within External Manufacturing Serialization. You will coordinate labeling attributes, GS1 identifiers, and master data with CMOs/3PLs, while managing validations and quality events under QMS.

This on-site role requires DSCSA/EU-FMD knowledge and hands-on Tracelink experience. The position involves cross-functional collaboration, change control ownership, and tracking